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Contents Chapter 3: Gastrointestinal Cancer ............................................................................. 4 Oesophageal Carcinoma .............................................................................................. 4 Adjuvant .................................................................................................................. 4 Neoadjuvant ............................................................................................................ 4 Cisplatin/Fluorouracil (5FU) .................................................................................. 4 Cisplatin/capecitabine .......................................................................................... 4 Locally advanced - Chemo-radiation protocol ......................................................... 5 Cisplatin/5FU ........................................................................................................ 5 Cisplatin/Fluorouracil (5FU) .................................................................................. 5 Cisplatin/capecitabine (see alternative SCOPE regimen also) ............................. 5 Cisplatin/Capecitabine + XRT (SCOPE trial protocol) .......................................... 6 Metastatic ................................................................................................................ 7 Cisplatin/5FU ........................................................................................................ 7 Cisplatin/capecitabine .......................................................................................... 7 Gastric / Adenocarcinomas of Gastro-oesophageal junction Carcinoma ................ 8 Neoadjuvant / Adjuvant ........................................................................................... 8 ECF/X................................................................................................................... 8 Adjuvant .................................................................................................................. 9 EOF/X .................................................................................................................. 9 Locally advanced / metastatic ............................................................................... 10 ECF/X................................................................................................................. 10 EOF/X ................................................................................................................ 11 Cisplatin/fluoropyrimidine/Herceptin (HCF/X) ..................................................... 12 Second line ........................................................................................................... 13 Irinotecan ........................................................................................................... 13 Docetaxel ........................................................................................................... 13 Weekly Paclitaxel ............................................................................................... 14 Pancreatic cancer........................................................................................................ 15 Adjuvant ................................................................................................................ 15 Fluorouracil/Folinic Acid ..................................................................................... 15 Gemcitabine ....................................................................................................... 15 Advanced .............................................................................................................. 16 First line .............................................................................................................. 16 Gemcitabine + Capecitabine .............................................................................. 16 Gemcitabine ....................................................................................................... 17 Second line ........................................................................................................... 17 Ox-Cap ............................................................................................................... 17 OxMdG ............................................................................................................... 18 Folfirinox............................................................................................................. 18 Cholangiocarcinoma / Gall Bladder Carcinoma ....................................................... 19 Advanced .............................................................................................................. 19 Gemcitabine + Cisplatin ..................................................................................... 19 Gemcitabine ....................................................................................................... 20 ECF/ECX/EOF/EOX ........................................................................................... 20 Issue Date: March 2014 Page 1 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Hepatocellular carcinoma ........................................................................................... 22 *Sorafenib .......................................................................................................... 22 Neuroendocrine tumours ........................................................................................... 23 High mitotic rate, anaplastic histology, clinically aggressive .................................. 23 Etoposide / cisplatin ........................................................................................... 23 Low mitotic rate, well differentiated histology, clinically indolent ........................... 23 Somatostatin ...................................................................................................... 23 Pancreatic neuroendocrine tumours...................................................................... 24 *Everolimus (Afinitor®) ....................................................................................... 24 *Sunitinib ............................................................................................................ 24 Progression on first line therapy ............................................................................ 25 Streptozocin/Doxorubicin ................................................................................... 25 Octreotide ........................................................................................................... 25 Colorectal..................................................................................................................... 26 Adjuvant ................................................................................................................ 26 5FU/FA ............................................................................................................... 26 Capecitabine ...................................................................................................... 26 XELOX ............................................................................................................... 27 OxMdG ............................................................................................................... 27 Rectal cancer - Chemoradiation ............................................................................ 28 Capecitabine + XRT ........................................................................................... 28 5FU + XRT ......................................................................................................... 28 Downstaging of liver metastases prior to surgery .................................................. 29 Cetuximab OxMdG ............................................................................................. 29 Cetuximab Folfiri ................................................................................................ 29 Advanced Colorectal Cancer ................................................................................. 30 First line .............................................................................................................. 30 MdG ................................................................................................................... 30 Capecitabine ...................................................................................................... 30 FOLFIRI ............................................................................................................. 31 I-Cap .................................................................................................................. 31 OxMdG ............................................................................................................... 32 Ox-Cap ............................................................................................................... 32 XELOX ............................................................................................................... 33 Cetuximab Folfiri ................................................................................................ 33 Cetuximab OxMdG ............................................................................................. 34 Panitumumab OxMdG ........................................................................................ 37 Raltitrexed .......................................................................................................... 38 TomOx ............................................................................................................... 38 Second / third line chemotherapy .......................................................................... 39 Irinotecan + MdG (see above) ............................................................................ 39 Oxaliplatin + MdG ............................................................................................... 39 I-Cap .................................................................................................................. 39 Ox-Cap ............................................................................................................... 39 Irinotecan ........................................................................................................... 39 *Bevacizumab .................................................................................................... 40 *Irinotecan + Cetuximab ..................................................................................... 41 Issue Date: March 2014 Page 2 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: MMC + MdG ....................................................................................................... 43 MMC + Capecitabine .......................................................................................... 44 Anal Carcinoma ........................................................................................................... 44 Localised squamous carcinoma of the anus ......................................................... 44 Combined XRT + chemotherapy ........................................................................ 44 Palliative / Metastatic............................................................................................. 45 Cisplatin/5FU ...................................................................................................... 45 Mitomycin C / Fluoropyrimidine .......................................................................... 46 Issue Date: March 2014 Page 3 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Chapter 3: Gastrointestinal Cancer Oesophageal Carcinoma Adjuvant Not currently recommended as standard therapy Neoadjuvant Cisplatin/Fluorouracil (5FU) Cisplatin/fluorouracil Frequency Course length Every 21 Days 2 cycles Drug Dose Admin 2 Day 1 Cisplatin 80mg/m Days 1 to 4 Fluorouracil 1000mg/m daily IV infusion over 90 minutes 2 IV infusion over 24 hours OR Cisplatin/capecitabine Cisplatin/capecitabine Frequency Course length Every 21 Days 2 cycles Drug Dose Admin 2 Day 1 Cisplatin 80mg/m Days 1 to 14 Capecitabine 1000mg/m BD Criteria IV infusion over 90 minutes Twice daily (morning and evening) orally, for 14 days followed by 7 days off 2 PS 0-1 Cr Cl > 50ml/min Operable oesophageal cancer NB see capecitabine renal function recommendations in chapter one Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Treatment to continue providing neutrophils > 1.0 x 10 /L and platelets > 100 x 10 /L 9 9 Issue Date: March 2014 Page 4 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Locally advanced - Chemo-radiation protocol Cisplatin/5FU Cisplatin/Fluorouracil (5FU) Cisplatin/fluorouracil Frequency Course length One treatment course 5 week course Drug Dose Admin 2 Day 1 Cisplatin 60 to 80mg/m Days 1 to 4 Fluorouracil 1000mg/m daily Day 29 Cisplatin 60 to 80mg/m Days 29 to 32 Fluorouracil 1000mg/m daily IV infusion over 90 minutes 2 IV infusion over 24 hours 2 IV infusion over 90 minutes 2 IV infusion over 24 hours Followed by two additional cycles after completion of XRT as below Cisplatin/fluorouracil Frequency Course length Every 21 Days 2 cycles Drug Dose Admin 2 Day 1 Cisplatin 60 to 80mg/m Days 1 to 4 Fluorouracil 1000mg/m daily IV infusion over 90 minutes 2 IV infusion over 24 hours OR Cisplatin/capecitabine (see alternative SCOPE regimen also) Cisplatin/capecitabine Frequency Course length One treatment course 5 week course Drug Dose Admin 2 Day 1 Cisplatin 60 to 80mg/m Days 1 to 35 Capecitabine 825mg/m BD Day 29 Cisplatin 60 to 80mg/m 2 2 IV infusion over 90 minutes Twice daily (morning and evening) orally, on radiotherapy days only IV infusion over 90 minutes Issue Date: March 2014 Page 5 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Followed by two additional cycles after completion of XRT as below Cisplatin/capecitabine Frequency Course length Every 21 Days 2 cycles Drug Dose Admin Day 1 Cisplatin 60 to 80mg/m Days 1 to 14 Capecitabine 1000mg/m BD 2 IV infusion over 90 minutes Twice daily (morning and evening) orally, for 14 days followed by 7 days off 2 Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Treatment to continue providing neutrophils > 1.0 x 10 /L and platelets > 100 x 10 /L 9 9 Cisplatin/Capecitabine + XRT (SCOPE trial protocol) Cisplatin/capecitabine Frequency Course length Every 21 Days Drug 4 cycles Dose Admin 2 Day 1 Cisplatin 60 to 80mg/m Days 1 to 21 Capecitabine 625mg/m BD IV infusion over 90 minutes Twice daily (morning and evening) orally continuously 2 Radiotherapy given concurrently with cycles 3 and 4 NB see capecitabine renal function recommendations and cisplatin hydration details in chapter one Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Treatment to continue providing neutrophils > 1.0 x 10 /L and platelets > 100 x 10 /L 9 9 Issue Date: March 2014 Page 6 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Metastatic Cisplatin/5FU Cisplatin/fluorouracil Frequency Course length Every 21 Days Drug 4 to 6 cycles Dose Admin 2 Day 1 Cisplatin 80mg/m Days 1 to 4 Fluorouracil 1000mg/m daily 2 IV infusion over 90 minutes IV infusion over 24 hours OR Cisplatin/capecitabine Cisplatin/capecitabine Frequency Course length Every 21 Days Drug 4 to 6 cycles Dose Admin 2 Day 1 Cisplatin 80mg/m Days 1 to 14 Capecitabine 1000mg/m BD 2 IV infusion over 90 minutes Twice daily (morning and evening) orally, for 14 days followed by 7 days off Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply NB see capecitabine renal function recommendations and cisplatin hydration details in chapter one Issue Date: March 2014 Page 7 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Gastric / Adenocarcinomas of Gastro-oesophageal junction Carcinoma Neoadjuvant / Adjuvant For patients with operable cancers after initial staging ECF/X x 3 cycles Surgery -- ECF/X x 3 cycles ECF/X ECF Frequency Course length Every 21 Days 3 + 3 cycles Drug Dose Admin Day 1 Epirubicin 50mg/m 2 Day 1 Cisplatin 60mg/m 2 Days 1 to 7 Fluorouracil 200mg/m /day Days 8 to 14 Fluorouracil 200mg/m /day Days 15 to 21 Fluorouracil 200mg/m /day IV bolus IV infusion over 90 minutes 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days OR ECX Frequency Course length Every 21 Days 3 + 3 cycles Drug Dose Admin Day 1 Epirubicin 50mg/m 2 Day 1 Cisplatin 60mg/m 2 Days 1 to 21 Capecitabine IV bolus IV infusion over 90 minutes Twice daily (morning and evening) orally continuously 2 625mg/m BD NB see capecitabine renal function recommendations and cisplatin hydration regimens in chapter one Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Treatment to continue providing neutrophils > 1.0 x 10 /L and platelets > 100 x 10 /L 9 9 Issue Date: March 2014 Page 8 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Adjuvant EOF/X EOF Frequency Course length Every 21 Days 6 cycles Drug Dose Admin 2 Day 1 Epirubicin 50mg/m Day 1 Oxaliplatin 130mg/m Days 1 to 7 Fluorouracil 200mg/m /day Days 8 to 14 Fluorouracil 200mg/m /day Days 15 to 21 Fluorouracil 200mg/m /day IV bolus 2 IV infusion over 2 hours 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days OR EOX Frequency Course length Every 21 Days 6 cycles Drug Dose Admin 2 Day 1 Epirubicin 50mg/m Day 1 Oxaliplatin 130mg/m Days 1 to 21 Capecitabine 625mg/m BD IV bolus 2 IV infusion over 2 hours Twice daily (morning and evening) orally continuously 2 NB see capecitabine renal function recommendations and cisplatin hydration details in chapter one Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Treatment to continue providing neutrophils > 1.0 x 10 /L and platelets > 100 x 10 /L 9 9 Issue Date: March 2014 Page 9 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Locally advanced / metastatic ECF/X ECF Frequency Course length Every 21 Days 4 to 6 cycles Drug Dose Admin Day 1 Epirubicin 50mg/m 2 Day 1 Cisplatin 60mg/m 2 Days 1 to 7 Fluorouracil 200mg/m /day Days 8 to 14 Fluorouracil 200mg/m /day Days 15 to 21 Fluorouracil 200mg/m /day IV bolus IV infusion over 90 minutes 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days OR ECX Frequency Course length Every 21 Days 4 to 6 cycles Drug Dose Admin Day 1 Epirubicin 50mg/m 2 Day 1 Cisplatin 60mg/m 2 Days 1 to 21 Capecitabine 625mg/m BD 2 IV bolus IV infusion over 90 minutes Twice daily (morning and evening) orally continuously NB see capecitabine renal function recommendations and cisplatin hydration details in chapter one Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 10 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: EOF/X EOF Frequency Course length Every 21 Days 6 cycles Drug Dose Admin 2 Day 1 Epirubicin 50mg/m Day 1 Oxaliplatin 130mg/m Days 1 to 7 Fluorouracil 200mg/m /day Days 8 to 14 Fluorouracil 200mg/m /day Days 15 to 21 Fluorouracil 200mg/m /day IV bolus 2 IV infusion over 2 hours 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days OR EOX Frequency Course length Every 21 Days 6 cycles Drug Dose Admin 2 Day 1 Epirubicin 50mg/m Day 1 Oxaliplatin 130mg/m Days 1 to 21 Capecitabine 625mg/m BD 2 IV bolus 2 IV infusion over 2 hours Twice daily (morning and evening) orally continuously NB see capecitabine renal function recommendations in chapter one Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 11 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Cisplatin/fluoropyrimidine/Herceptin (HCF/X) HCF/X HCF Frequency Course length Every 21 Days 6 cycles Drug Dose Admin Day 1 Cycle 1 Trastuzumab 8mg/kg IV infusion over 90 minutes Day 1 subsequent cycles Trastuzumab 6mg/kg IV infusion over 30 to 60 minutes Day 1 Cisplatin 80mg/m Days 1 to 4 Fluorouracil 1000mg/m daily 2 2 IV infusion over 90 minutes IV infusion over 24 hours OR HCX Frequency Course length Every 21 Days 6 cycles Drug Dose Admin Day 1 Cycle 1 Trastuzumab 8mg/kg IV infusion over 90 minutes Day 1 subsequent cycles Trastuzumab 6mg/kg IV infusion over 30 to 60 minutes Day 1 Cisplatin 80mg/m Days 1 to 14 Capecitabine 1000mg/m BD 2 2 IV infusion over 90 minutes Twice daily (morning and evening) orally for 7 days, following by 7 days off Continue with single agent trastuzumab from cycle 7 Trastuzumab Cycle 7 onwards Criteria Frequency Course length Every 21 Days Until disease progression Drug Dose Admin Trastuzumab 6mg/kg IV infusion over 30 mins PS 0-1 Cr Cl > 50ml/min HER 2 status IHC 3+ or FISH positive LVEF: baseline ECHO/MUGA + 3 monthly repeat advised for patients receiving treatment with trastuzumab Issue Date: March 2014 Page 12 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply NB see capecitabine renal function recommendations and cisplatin hydration details in chapter one Second line Irinotecan Irinotecan Day 1 Day 1 Frequency Course length Every 21 Days 4 cycles Drug Dose Atropine 600 micrograms Irinotecan Admin 250mg/m 2 Subcutaneous injection prior to irinotecan IV infusion over 30 to 90 minutes as tolerated 2 Option to increase to 350mg/m if well tolerated Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Docetaxel Docetaxel Frequency Course length Every 21 Days Upto 6 cycles Drug Dose Dexamethasone 8mg BD Docetaxel 75mg/m Day 1 2 Admin Orally for 3 days, commencing 24 hours before docetaxel IV infusion over 60 minutes Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Issue Date: March 2014 Page 13 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Normal FBC limits for administration apply Weekly Paclitaxel Weely paclitaxel Frequency Course length Every 7 days Until disease progression Drug Dose Admin Day 1 Chlorphenamine 10mg IV bolus Day 1 Dexamethasone 8mg IV bolus Reducing to 4mg from week 2 Day 1 Ranitidine 50mg IV bolus Day 1 Paclitaxel 80mg/m 2 IV infusion over 60 minutes Criteria: Alternative regimen to docetaxel for patients unable to tolerate PS 2 Laboratory investigations Patients with abnormal hepatic function should be treated cautiously Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle. Normal limits for administration apply with the exception that for patients with marrow infiltration treatment may be continued at lower platelet and neutrophil counts at treating physician discretion. Issue Date: March 2014 Page 14 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Pancreatic cancer Adjuvant Fluorouracil/Folinic Acid Fluorouracil/Folinic Acid Frequency Course length Every 28 Days 6 cycles Drug Dose Days 1 to 5 Fluorouracil 425mg/m Day 1 to 5 Folinic Acid 50mg Admin 2 IV bolus, daily IV bolus, daily NB: For patients over 70 years and those with borderline performance status the dose of fluorouracil 2 should be reduced to 370mg/m per day. Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Gemcitabine Gemcitabine Frequency Course length Every 28 Days 6 cycles Drug Dose Admin Day 1 Gemcitabine 1000mg/m 2 Day 8 Gemcitabine 1000mg/m 2 IV infusion over 30 minutes Day 15 Gemcitabine 1000mg/m 2 IV infusion over 30 minutes Criteria IV infusion over 30 minutes PS 0-2 R0, R1 resection M0 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated NB: transaminases may rise during gemcitabine therapy Where renal / hepatic function are abnormal treatment is at physician discretion Issue Date: March 2014 Page 15 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: FBC prior to each cycle Normal FBC limits for administration apply Advanced First line Gemcitabine + Capecitabine Gemcitabine + Capecitabine Frequency Course length Every 28 Days Upto 6 cycles Drug Dose Admin 2 Day 1 Gemcitabine 1000mg/m Days 1 to 21 Capecitabine 825mg/m BD Day 8 Gemcitabine 1000mg/m 2 IV infusion over 30 minutes Day 15 Gemcitabine 1000mg/m 2 IV infusion over 30 minutes 2 IV infusion over 30 minutes Twice daily (morning and evening) orally continuously NB see capecitabine renal function recommendations see chapter one Criteria PS 0-1 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles NB: transaminases may rise during gemcitabine therapy Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle CA19-9 every 4 weeks Day 8 or 15 9 Platelets 75 – 99 x10 /L continue at full dose 9 Platelets < 75x10 /L omit gemcitabine Issue Date: March 2014 Page 16 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Gemcitabine Gemcitabine Frequency Course length Every 28 Days 6 cycles Drug Dose Admin Day 1 Gemcitabine 1000mg/m 2 Day 8 Gemcitabine 1000mg/m 2 IV infusion over 30 minutes Day 15 Gemcitabine 1000mg/m 2 IV infusion over 30 minutes IV infusion over 30 minutes Or IV weekly for seven weeks followed by one week break for first cycle then 3 weeks on, one off as above. Criteria PS 0-2 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated NB: transaminases may rise during gemcitabine therapy Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle CA19-9 every 4 weeks Day 8 or 15 9 Platelets 75 – 99 x10 /L continue at full dose 9 Platelets < 75x10 /L omit gemcitabine Second line Ox-Cap Ox-Cap Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin 2 Day 1 Oxaliplatin 85mg/m Days 1 to 9 Capecitabine 900mg/m BD 2 IV infusion over 2 hours Twice daily (morning and evening) orally for 9 days, followed by 5 days off NB see capecitabine renal function recommendations see chapter one Criteria PS 0-2 Relapse < 6 months post adjuvant chemotherapy Progression free interval > 3 months following first line therapy Laboratory Investigations Issue Date: March 2014 Page 17 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC and creatinine prior to each cycle Normal FBC limits for administration apply with the exception that the lower limit for platelets for 9 administration of Ox-Cap is 75 x 10 /L OxMdG OxMdG Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin 2 Day 1 Oxaliplatin 85mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m IV infusion over 2 hours IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion Avoid in patients with pre-existing neuropathy Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply with the exception that the lower limit for platelets for 9 administration of OxMdG is 75 x 10 /L Folfirinox Folfirinox Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin 2 Day 1 Oxaliplatin 85mg/m Day 1 Atropine 600 micrograms Day 1 Irinotecan 180mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m IV infusion over 2 hours 2 Subcutaneous injection prior to irinotecan IV infusion over 30 to 90 minutes IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion Issue Date: March 2014 Page 18 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: 5FU bolus to be omitted in patients at risk of prolonged immunosuppression from previous treatment Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Cholangiocarcinoma / Gall Bladder Carcinoma Advanced Gemcitabine + Cisplatin Gem/Cis Frequency Course length Every 21 Days Upto 6 cycles Drug Dose Admin Day 1 Gemcitabine 1000mg/m Day 1 Cisplatin 25mg/m Day 8 Gemcitabine 1000mg/m Day 8 Cisplatin 25mg/m Criteria 2 2 2 IV infusion over 30 minutes IV infusion over 60 minutes 2 IV infusion over 30 minutes IV infusion over 60 minutes PS 0-1 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle CA19-9 every 4 weeks Normal FBC limits for administration apply Issue Date: March 2014 Page 19 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Gemcitabine Gemcitabine Frequency Course length Every 28 Days 6 cycles Drug Dose Admin Day 1 Gemcitabine 1000mg/m 2 Day 8 Gemcitabine 1000mg/m 2 IV infusion over 30 minutes Day 15 Gemcitabine 1000mg/m 2 IV infusion over 30 minutes Criteria IV infusion over 30 minutes PS 0-2 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle CA19-9 every 4 weeks Normal FBC limits for administration apply ECF/ECX/EOF/EOX ECF Frequency Course length Every 21 Days Upto 6 cycles Drug Dose Admin Day 1 Epirubicin 50mg/m 2 Day 1 Cisplatin 60mg/m 2 Days 1 to 7 Fluorouracil 200mg/m /day Days 8 to 14 Fluorouracil 200mg/m /day Days 15 to 21 Fluorouracil 200mg/m /day IV bolus IV infusion over 90 minutes 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days OR ECX Frequency Course length Every 21 Days Upto 6 cycles Drug Dose Admin Day 1 Epirubicin 50mg/m 2 Day 1 Cisplatin 60mg/m 2 Days 1 to 21 Capecitabine 625mg/m BD 2 IV bolus IV infusion over 90 minutes Twice daily (morning and evening) orally continuously Issue Date: March 2014 Page 20 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: OR EOF Frequency Course length Every 21 Days Upto 6 cycles Drug Day 1 Day 1 Days 1 to 7 Days 8 to 14 Days 15 to 21 Dose Epirubicin 50mg/m Oxaliplatin Fluorouracil Fluorouracil Fluorouracil Admin 2 130mg/m 2 IV bolus IV infusion over 2 hours 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days 2 Continuous IV infusion over 7 days 200mg/m /day 200mg/m /day 200mg/m /day OR EOX Frequency Course length Every 21 Days Upto 6 cycles Drug Day 1 Dose Epirubicin 50mg/m Admin 2 Day 1 Oxaliplatin 130mg/m Days 1 to 21 Capecitabine 625mg/m BD 2 IV bolus 2 IV infusion over 2 hours Twice daily (morning and evening) orally continuously NB see capecitabine renal function recommendations and cisplatin hydration details see chapter one Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 21 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Hepatocellular carcinoma *Sorafenib Sorafenib Frequency Course length Continuous, supply every 4 weeks Until disease progression Daily Drug Dose Admin Sorafenib 400mg BD Orally, daily Commence at 200mg BD initially, and increase as tolerated *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) The first line treatment of advanced hepatocellular carcinoma where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Hepatocellular carcinoma 3. a) Child-Pugh grade A liver impairment OR b) Child-Pugh grade B liver impairment with low disease burden 4. No previous systemic therapy 5. No role for surgery or after failure of surgery or after failure of locoregional therapy Laboratory investigations FBC, U/Es, LFTs prior to each cycle Where renal / hepatic function are abnormal treatment is at physician discretion Discontinue if deteriorating renal or liver function Normal FBC limits for administration apply Issue Date: March 2014 Page 22 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Neuroendocrine tumours High mitotic rate, anaplastic histology, clinically aggressive Etoposide / cisplatin Etoposide/cisplatin Frequency Course length Every 21 Days Upto 6 cycles Drug Dose Admin 2 Day 1 Etoposide 120mg/m Day 1 Cisplatin 70mg/m Day 2 Etoposide 120mg/m 2 IV infusion over 2 hours Day 3 Etoposide 120mg/m 2 IV infusion over 2 hours Criteria 2 IV infusion over 2 hours IV infusion over 90 minutes PS 0-1 Cr Cl > 50ml/min Patients with rapidly progressive disease NB see cisplatin hydration details see chapter one Laboratory investigations Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Low mitotic rate, well differentiated histology, clinically indolent Somatostatin short acting analogue titrated to achieve maximum benefit then switch to long acting preparation Issue Date: March 2014 Page 23 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Pancreatic neuroendocrine tumours *Everolimus (Afinitor®) Everolimus Frequency Course length Continuous, supplied every 28 days Until disease progression / toxicity Daily Drug Dose Admin Everolimus 10mg Orally, daily Laboratory Investigations Ensure normal renal and hepatic function prior to each cycle 1 Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Baseline blood glucose and triglycerides, repeat as indicated *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) The treatment of pancreatic neuroendocrine carcinomas where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Pancreatic neuroendocrine carcinomas 3. a) 1st line indication, OR, b) 2nd line indication *Sunitinib Sunitinib Frequency Course length Continuous, supplied every 28 days Until disease progression / toxicity Daily Drug Dose Admin Sunitinib 37.5mg Orally, daily Laboratory Investigations Ensure normal renal and hepatic function prior to each cycle 1 Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 24 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) The treatment of pancreatic neuroendocrine carcinomas where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Biopsy proven well differentiated pancreatic neuroendocrine tumour st 3. a) 1 line indication, OR, nd b) 2 line indication, OR, rd c) 3 line indication 4. No previous VEGF targeted therapy Progression on first line therapy Streptozocin/Doxorubicin Streptozocin/Doxorubicin Frequency Course length Every 42 Days Until disease progression or toxicity Drug Dose Admin 2 Days 1 to 5 Streptozocin 500mg/m Day 1 Doxorubicin 50mg/m 2 IV bolus Day 22 Doxorubicin 50mg/m 2 IV bolus IV infusion, daily for 5 days Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Octreotide Octreotide LAR 20-30mg IM monthly Criteria Non-functioning neuroendocrine tumour of mid gut or uncertain primary origin Locally inoperable or metastatic disease Well differentiated histology Issue Date: March 2014 Page 25 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Colorectal Adjuvant 5FU/FA 5FU/FA Frequency Course length weekly For 24 weeks Drug Dose Admin Day 1 Folinic acid 50mg IV bolus, weekly Day 1 Fluorouracil 370mg/m 2 IV bolus, weekly Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to every fourth week Normal FBC limits for administration apply Capecitabine Capecitabine Days 1 to 14 Frequency Course length Every 21 days 8 cycles Drug Dose Capecitabine 1250mg/m BD 2 Admin Twice daily (morning and evening) orally, for 14 days followed by 7 days off 2 Consider 1000mg/m for patients over 70yrs NB see capecitabine renal function recommendations in chapter 1 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Repeat creatinine if clinically indicated Normal FBC limits for administration apply Issue Date: March 2014 Page 26 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: XELOX Oxaliplatin/Capecitabine Frequency Course length Every 21 days 8 cycles Drug Dose Admin 2 Day 1 Oxaliplatin 130 mg/m Days 1 to 14 Capecitabine 1000mg/m BD 2 IV infusion over 2 hours Twice daily (morning and evening) orally, for 14 days followed by 7 days off NB see capecitabine renal function recommendations in chapter 1 Consider carefully in patients with pre-existing neuropathy Consider omitting oxaliplatin if persistent neuropathy develops. Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle. Normal FBC limits for administration apply. OxMdG OxMdG Frequency Course length Every 14 Days 12 cycles Drug Dose Day 1 Oxaliplatin 85mg/m Day 1 Folinic acid 350mg Admin 2 IV infusion over 2 hours IV infusion over 2 hours 2 Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m 2 IV bolus over 15 minutes 46 hour continuous IV infusion Consider carefully in patients with pre-existing neuropathy Consider omitting oxaliplatin if persistent neuropathy develops. Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply with the exception that the lower limit for platelets for 9 administration of OxMdG is 75 x 10 /L Issue Date: March 2014 Page 27 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Rectal cancer - Chemoradiation Capecitabine + XRT Capecitabine Days 1 to 25 of radiotherapy Frequency Course length One course 5 weeks with radiotherapy Drug Dose Capecitabine 825mg/m BD 2 Admin Twice daily (morning and evening) orally Monday to Friday only during radiotherapy NB see capecitabine renal function recommendations in chapter 1 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion Normal FBC limits for administration apply 5FU + XRT Fluorouracil infusion Frequency Course length One course Drug 5 weeks Dose Admin 2 IV infusion over 24 hours 2 IV infusion over 24 hours Day 1 to 4 Fluorouracil 1000mg/m daily Days 22 to 26 Fluorouracil 1000mg/m daily OR 5FU/FA Frequency Course length weekly 5 weeks Drug Dose Admin Day 1 Folinic acid 50mg IV bolus, weekly Day 1 Fluorouracil 300mg/m 2 IV bolus, weekly Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each 5FU infusion, or with week 1 and week 4 of bolus 5FU Normal FBC limits for administration apply Issue Date: March 2014 Page 28 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Downstaging of liver metastases prior to surgery Criteria KRAS wild type cancer PS 0-1 Metastatic disease confined to the liver and potentially resectable if downsized Primary resected or resectable Cetuximab OxMdG Cetuximab OxMdG Frequency Course length Every 14 Days Total 16 weeks Drug Dose Admin Day 1 Dexamethasone 8mg IV bolus Day 1 Chlorphenamine 10mg IV bolus Day 1 Cetuximab 500mg/m Day 1 Oxaliplatin 85mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m IV infusion, over 2 hours for first dose, then reduce to 1 hour as tolerated 2 2 IV infusion over 2 hours IV infusion over 2 hours 2 IV bolus over 15 minutes 2 46 hour continuous IV infusion Cetuximab Folfiri Cetuximab Folfiri Frequency Course length Every 14 Days Total 16 weeks Drug Dose Admin Day 1 Dexamethasone 8mg IV bolus Day 1 Chlorphenamine 10mg IV bolus Day 1 Cetuximab 500mg/m Day 1 Atropine 600 micrograms Day 1 Irinotecan 180mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m 2 2 IV infusion, over 2 hours for first dose, then reduce to 1 hour as tolerated Subcutaneous injection prior to irinotecan IV infusion IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC and biochemistry prior to each cycle Issue Date: March 2014 Page 29 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Normal FBC limits for administration apply with the exception that the lower limit for platelets for 9 administration is 75 x 10 /L Advanced Colorectal Cancer First line MdG MdG Frequency Course length Every 14 Days 6 cycles, then reassess Drug Dose Admin Day 1 Folinic acid 350mg IV infusion over 2 hours Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2800mg/m 2 IV bolus over 15 minutes 2 46 hour continuous IV infusion 2 Fluorouracil dose can be reduced to 2400mg/m in patients with poorer PS Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Capecitabine Capecitabine Frequency Course length Every 21 days 6 cycles and then reassess Drug Days 1 to 14 Capecitabine Dose 2 1250mg/m BD Admin Twice daily (morning and evening) orally, for 14 days followed by 7 days off 2 Consider 1000mg/m for patients over 70yrs NB see capecitabine renal function recommendations in chapter 1 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC and creatinine prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 30 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: FOLFIRI FOLFIRI (IrMdG) Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin Day 1 Atropine 600 micrograms Subcutaneous injection prior to irinotecan Day 1 Irinotecan 180mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m 2 IV infusion IV infusion over 2 hours 2 IV bolus over 15 minutes 2 46 hour continuous IV infusion Review after 12 weeks and consider continuing to 24 weeks if: SD / response. Acceptable toxicity Criteria: PS 0-2 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply I-Cap I-Cap Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin Day 1 Atropine 600 micrograms Subcutaneous injection prior to irinotecan Day 1 Irinotecan 180mg/m 2 IV infusion Days 1 to 9 Capecitabine 900mg/m 2 Twice daily (morning and evening) orally, for 9 days followed by 5 days off NB see capecitabine renal function recommendations see chapter 1 Review after 12 weeks and consider continuing to 24 weeks if response and acceptable toxicity Criteria: PS 0-1 Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC and creatinine prior to each cycle Issue Date: March 2014 Page 31 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Normal FBC limits for administration apply OxMdG OxMdG Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin 2 Day 1 Oxaliplatin 85mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m IV infusion over 2 hours IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion Avoid in patients with pre-existing neuropathy Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply with the exception that the lower limit for platelets for 9 administration of OxMdG is 75 x 10 /L Ox-Cap Ox-Cap Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin 2 Day 1 Oxaliplatin 85mg/m Days 1 to 9 Capecitabine 900mg/m 2 IV infusion Twice daily (morning and evening) orally, for 9 days followed by 5 days off NB see capecitabine renal function recommendations see chapter 1 Avoid in patients with pre-existing neuropathy Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC and creatinine prior to each cycle Normal FBC limits for administration apply with the exception that the lower limit for platelets for 9 administration of Ox-Cap is 75 x 10 /L Issue Date: March 2014 Page 32 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: XELOX Xelox Frequency Course length Every 21 Days 4 cycles then reassess Drug Dose Admin 2 Day 1 Oxaliplatin 130mg/m Days 1 to 14 Capecitabine 1000mg/m 2 IV infusion over 2 hours Twice daily (morning and evening) orally, for 14 days followed by 7 days off NB see capecitabine renal function recommendations see chapter 1 Avoid in patients with pre-existing neuropathy Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply. Cetuximab Folfiri Cetuximab Folfiri Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin Day 1 Dexamethasone 8mg IV bolus Day 1 Chlorphenamine 10mg IV bolus Day 1 Cetuximab 500mg/m Day 1 Atropine 600 micrograms Day 1 Irinotecan 180mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m 2 2 IV infusion, over 2 hours for first dose, then reduce to 1 hour as tolerated Subcutaneous injection prior to irinotecan IV infusion over 90 minutes IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC and biochemistry prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 33 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: *NB available via the Cancer Drugs fund - Cetuximab (in combination with irinotecan based chemotherapy) th CDF Criteria (as at 13 February 2014) The first line treatment of metastatic colorectal cancer where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy. 2. Metastatic colorectal cancer 3. 1st line indication 4. Patients with wild-type RAS 5. Given in combination with irinotecan-based combination chemotherapy 2 6. Cetuximab given as a 2 weekly regimen at a dose of 500mg/m 7. Not eligible for NICE TA176 approved indications (including patients who have not progressed despite receiving the NICE approved 16 weeks treatment) 8. No previous treatment with cetuximab or panitumumab st NOTE: Cetuximab is not approved for use as 1 line treatment with any oxaliplatin-based combination other than FOLFOX4 or with upfront single agent fluoropyrimidine chemotherapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with irinotecan, cetuximab can be continued with a fluoropyrimidine alone until disease progression only. Cetuximab OxMdG Cetuximab OxMdG Frequency Course length Every 14 Days 6 cycles and reassess Drug Dose Admin Day 1 Dexamethasone 8mg IV bolus Day 1 Chlorphenamine 10mg IV bolus Day 1 Cetuximab 500mg/m Day 1 Oxaliplatin 85mg/m Day 1 Folinic acid 350mg Day 1 Day 1 Fluorouracil Fluorouracil 2 2 400mg/m IV infusion, over 2 hours for first dose, then reduce to 1 hour as tolerated IV infusion over 2 hours IV infusion over 2 hours 2 2400mg/m 2 IV bolus over 15 minutes 46 hour continuous IV infusion Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC and biochemistry prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 34 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: *NB available via the Cancer Drugs th CDF Criteria (as at 13 February 2014) The first line treatment of metastatic colorectal cancer where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy. 2. Metastatic colorectal cancer 3. 1st line indication 4. Patients with wild-type RAS 5. Given in combination with FOLFOX4 or FOLFOX6 or OxMdG chemotherapy regimens 2 6. Cetuximab given as a 2 weekly regimen at a dose of 500mg/m 7. Not eligible for NICE TA176 approved indications (including patients who have not progressed despite receiving the NICE approved 16 weeks treatment) 8. No previous treatment with cetuximab or panitumumab st NOTE: Cetuximab is not approved for use as 1 line treatment with any other oxaliplatin-based regimens or with upfront single agent fluoropyrimidine chemotherapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with irinotecan, cetuximab can be continued with a fluoropyrimidine alone until disease progression only. *Bevacizumab (In combination with a single agent fluoropyrimidine) 14 day schedules: Bevacizumab 5mg/kg IV infusion 21 day schedules Bevacizumab 7.5mg/kg IV infusion Bev-Cap Frequency Course length Every 21 Days 6 cycles then reassess Drug Dose Admin Day 1 Bevacizumab 7.5mg/kg IV infusion over 90 minutes for first infusion, then 30 to 60 minutes as tolerated Days 1 to 14 Capecitabine 1000mg/mg BD 2 Twice daily (morning and evening) orally, for 14 days followed by 7 days off Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion Proteinuria monitoring BP at each cycle FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 35 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) The first line treatment of advanced colorectal cancer with a single agent fluoropyrimidine where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Advanced colorectal cancer 3. PS 0-2 4. Given in combination with a single agent fluoropyrimidine as 1st line treatment 5. Patient assessed as unfit to receive combination oxaliplatin- or irinotecan-based combination chemotherapy 6. No previous treatment with bevacizumab Note: Bevacizumab is not approved for use as a single agent maintenance therapy on its own. Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) *Bevacizumab (With irinotecan or oxaliplatin based chemotherapy) 14 day schedules: Bevacizumab 5mg/kg IV infusion 21 day schedules Bevacizumab 7.5mg/kg IV infusion BevFolFox Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin IV infusion over 90 minutes for first infusion, then 30 to 60 minutes as tolerated Day 1 Bevacizumab 5mg/kg Day 1 Oxaliplatin 85mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m 2 IV infusion over 2 hours IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion OR BevFolFiri Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Day 1 Bevacizumab 5mg/kg Day 1 Atropine 600 micrograms Day 1 Irinotecan 180mg/m Day 1 Folinic acid 350mg Day 1 Day 1 Fluorouracil Fluorouracil 400mg/m Admin IV infusion over 90 minutes for first infusion, then 30 to 60 minutes as tolerated 2 Subcutaneous injection prior to irinotecan IV infusion over 90 minutes IV infusion over 2 hours 2 2400mg/m 2 IV bolus over 15 minutes 46 hour continuous IV infusion Issue Date: March 2014 Page 36 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion Proteinuria monitoring and BP at each cycle Normal FBC limits for administration apply *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) The first line treatment of advanced colorectal cancer with combination chemotherapy where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Advanced Colorectal Cancer 3. 1st line indication 4. a) Given in combination with oxaliplatin-based combination chemotherapy OR b) Given in combination with irinotecan-based combination chemotherapy 5. No previous treatment with bevacizumab Note: If excessive toxicity with oxaliplatin or irinotecan, bevacizumab can be continued with a fluoropyrimidine alone until disease progression only. Note: Bevacizumab is ONLY approved for use in combination with chemotherapy and is not approved for use as a single agent maintenance therapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Panitumumab OxMdG Panitumumab OxMdG Frequency Course length Every 14 Days Drug Dose Admin IV infusion over 60 minutes for first infusion, then 30 to 60 minutes as tolerated Day 1 Panitumumab 6mg/kg Day 1 Oxaliplatin 85mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m 2 IV infusion over 2 hours IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat prior to subsequent cycles Where renal / hepatic function are abnormal treatment is at physician discretion FBC and biochemistry prior to each cycle Normal FBC limits for administration apply *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) Issue Date: March 2014 Page 37 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: The first line treatment of metastatic colorectal cancer where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Metastatic colorectal cancer 3. 1st line indication 4. Patients with wild-type RAS 5. Given in combination with the FOLFOX4 or FOLFOX6 or OxMdG chemotherapy regimen 6. No previous treatment with panitumumab or cetuximab st Note: Panitumumab is not approved for use as 1 line treatment with other oxaliplatin-based regimens, irinotecan based combinations, or upfront single agent fluoropyrimidine chemotherapy and is not st approved for use in any line of therapy after 1 line treatment Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with oxaliplatin, panitumumab can be continued with a fluoropyrimidine alone until disease progression only. Raltitrexed Raltitrexed Frequency Course length Every 21 days 6 cycles Drug Day 1 Criteria: Raltitrexed Dose 3mg/m Admin 2 IV infusion over 15 minutes Patients intolerant of fluoropyrimidines Laboratory Investigations Prior to the initiation and before each subsequent treatment, FBC, liver transanimases, serum bilirubin and serum creatinine should be performed. In the event of toxicity the next scheduled dose should be withheld until signs of toxic effects regress. Normal FBC limits for administration apply TomOx TomOx Frequency Course length Every 21 days 6 cycles Drug Dose Admin 2 Day 1 Raltitrexed 3mg/m Day 1 Oxaliplatin 100mg/m IV infusion over 15 minutes 2 IV infusion over 2 hours Laboratory Investigations Prior to the initiation and before each subsequent treatment, FBC, liver transanimases, serum bilirubin and serum creatinine should be performed. In the event of toxicity the next scheduled dose should be withheld until signs of toxic effects regress. Normal FBC limits for administration apply Issue Date: March 2014 Page 38 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Second / third line chemotherapy Irinotecan + MdG (see above) Oxaliplatin + MdG (see above) I-Cap (see above) Ox-Cap (see above) Irinotecan Irinotecan Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin Day 1 Atropine 600 micrograms Subcutaneous injection prior to irinotecan Day 1 Irinotecan 180mg/mg 2 IV infusion OR Irinotecan Frequency Course length Every 21 Days 6 cycles then reassess Drug Dose Admin Day 1 Atropine 600 micrograms Subcutaneous injection prior to irinotecan Day 1 Irinotecan 350mg/mg 2 IV infusion 2 Consider reducing to 300mg/m for patients over the age of 70 years Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 39 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: *Aflibercept IrMdG Aflibercept + FOLFIRI Frequency Course length Every 14 Days Day 1 6 cycles then reassess Drug Dose Aflibercept 4mg/kg Day 1 Irinotecan 180mg/m Day 1 Folinic acid 350mg Day 1 Day 1 Fluorouracil 400mg/m Fluorouracil Admin IV infusion over 60 minutes 2 IV infusion IV infusion over 2 hours 2 2400mg/m IV bolus over 15 minutes 2 46 hour continuous IV infusion *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) The second line treatment of colorectal cancer where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Metastatic colorectal cancer 3. PS 0 - 2 4. Progression following first line treatment with oxaliplatin based combination chemotherapy with or without bevacizumab 5. Given with irinotecan combination chemotherapy until unacceptable toxicity or disease progression NOTE: Aflibercept is ONLY approved for use in combination with irinotecan based combination chemotherapy and is not approved as a single agent maintenance therapy NOTE: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) *Bevacizumab 14 day schedules: Bevacizumab 5mg/kg IV infusion 21 day schedules Bevacizumab 7.5mg/kg IV infusion BevFolFox Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin IV infusion over 90 minutes for first infusion, then 30 to 60 minutes as tolerated Day 1 Bevacizumab 5mg/kg Day 1 Oxaliplatin 85mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m 2 IV infusion IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) Issue Date: March 2014 Page 40 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: The second or third line treatment of advanced colorectal cancer where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Advanced Colorectal Cancer 3. a) 2nd line indication, OR, b) 3rd line indication 4. No previous treatment with bevacizumab 5. Given in combination with oxaliplatin-based combination chemotherapy Note: If excessive toxicity with oxaliplatin, bevacizumab can be continued with a fluoropyrimidine alone until disease progression only. Note: Bevacizumab is ONLY approved for use in combination with oxaliplatin-based combination chemotherapy and is not approved for use as a single agent maintenance therapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) *Irinotecan + Cetuximab Cetux + IrMdG Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin Day 1 Dexamethasone 8mg IV bolus Day 1 Chlorphenamine 10mg IV bolus Day 1 Cetuximab 500mg/m Day 1 Atropine 600 micrograms Day 1 Irinotecan 180mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m Day 1 Fluorouracil 2400mg/m 2 2 IV infusion, over 2 hours for first dose, then reduce to 1 hour as tolerated Subcutaneous injection prior to irinotecan IV infusion IV infusion over 2 hours 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion OR Cetux + IrMdG Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin Day 1 Dexamethasone 8mg IV bolus Day 1 Chlorphenamine 10mg IV bolus Day 1 Cetuximab 500mg/m Day 1 Atropine 600 micrograms Day 1 Irinotecan 180mg/m 2 2 IV infusion, over 2 hours for first dose, then reduce to 1 hour as tolerated Subcutaneous injection prior to irinotecan IV infusion *NB available via the Cancer Drugs fund Issue Date: March 2014 Page 41 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: th CDF Criteria (as at 13 February 2014) The second or third line treatment of metastatic colorectal cancer with combination chemotherapy where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Metastatic colorectal cancer 3. a) 2nd line indication OR b) 3rd line indication 4. Patients with wild-type RAS 5. Given in combination with irinotecan-based chemotherapy 6. Performance status of 0 or 1 7. No previous treatment with cetuximab or panitumumab nd rd NOTE: Cetuximab is not approved for use as 2 or 3 line treatment with oxaliplatin-based combination or single agent fluoropyrimidine therapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with irinotecan, cetuximab can be continued with a fluoropyrimidine alone until disease progression only. And additionally – as above but see point 7 The second or third line treatment of metastatic colorectal cancer with combination chemotherapy where all the following criteria are met: 7. Response to previous cetuximab in the context of NICE TA176 and discontinuation at 16 weeks for consideration of surgery (and therefore not treated to disease progression) * Cetuximab single agent Cetuximab Frequency Course length Every 14 Days 6 cycles then reassess Drug Dose Admin Day 1 Dexamethasone 8mg IV bolus Day 1 Chlorphenamine 10mg IV bolus Day 1 Cetuximab 500mg/m 2 IV infusion, over 2 hours for first dose, then reduce to 1 hour as tolerated Continue until progression / unacceptable toxicity *NB available via the Cancer Drugs fund th CDF Criteria (as at 13 February 2014) The third or fourth line treatment of metastatic colorectal cancer as a single agent where all the following criteria are met: 1. Application made by and first cycle of systemic anti-cancer therapy to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy 2. Metastatic colorectal cancer 3. a) 3rd line indication b) 4th line indication 4. Patients with wild-type RAS 5. Performance status of 0 or 1 6. No previous treatment with cetuximab or panitumumab Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) And additionally – as above but see point 7 Issue Date: March 2014 Page 42 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: The second or third line treatment of metastatic colorectal cancer with combination chemotherapy where all the following criteria are met: 7. Response to previous cetuximab in the context of NICE TA176 and discontinuation at 16 weeks for consideration of surgery (and therefore not treated to disease progression) MMC + MdG Mitomycin + MdG Frequency Course length Every 42 days Drug Maximum 4 cycles Dose Admin 2 Day 1 Mitomycin C 7mg/m Day 1 Folinic acid 350mg Day 1 Fluorouracil 400mg/m IV bolus IV infusion over 2 hours 2 Day 1 Fluorouracil 2400mg/m Day 15 Folinic acid 350mg Day 15 Fluorouracil 400mg/m Fluorouracil 2400mg/m Day 29 Folinic acid 350mg Day 29 Fluorouracil Fluorouracil 400mg/m IV bolus over 15 minutes 46 hour continuous IV infusion IV infusion over 2 hours 2 Day 15 Day 29 2 2 IV bolus over 15 minutes 46 hour continuous IV infusion IV infusion over 2 hours 2 2400mg/m 2 IV bolus over 15 minutes 46 hour continuous IV infusion Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 43 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: MMC + Capecitabine Mitomycin C + Capecitabine Frequency Course length Every 42 Days Maximum 4 cycles Drug Dose Admin 2 Day 1 Mitomycin C 7mg/m Days 1 to 14 Capecitabine 1000mg/mg BD Days 22 to 35 Capecitabine 1000mg/mg BD IV bolus 2 2 Twice daily (morning and evening) orally, for 14 days followed by 7 days off Twice daily (morning and evening) orally, for 14 days followed by 7 days off NB see capecitabine renal function recommendations see chapter one Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC and biochemistry prior to each cycle Normal FBC limits for administration apply Anal Carcinoma Localised squamous carcinoma of the anus Combined XRT + chemotherapy Mitomycin C and Fluorouracil Frequency Course length Five week course One course Drug Day 1 Days 1 to 4 Days 29 to 32 Dose Admin 2 Mitomycin C 12mg/m Fluorouracil 2 IV infusion over 24 hours 2 IV infusion over 24 hours Fluorouracil 1000mg/m daily 1000mg/m daily IV bolus (maximum dose 20mg) OR Mitomycin C and Capecitabine Frequency Course length Five week course Drug One course Dose Admin 2 Day 1 Mitomycin C 12mg/m Days 1 to 35 Capecitabine 825mg/m BD 2 IV bolus (maximum dose 20mg) Twice daily (morning and evening) orally Monday to Friday, radiotherapy days only Issue Date: March 2014 Page 44 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: NB see capecitabine renal function recommendations see chapter one Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Palliative / Metastatic Cisplatin/5FU Cisplatin/fluorouracil Frequency Course length Every 21 Days 4 cycles Drug Dose Admin 2 Day 1 Cisplatin 60mg/m Days 1 to 4 Fluorouracil 1000mg/m daily IV infusion over 90 minutes (maximum dose 120mg) 2 IV infusion over 24 hours OR Cisplatin/capecitabine Frequency Course length Every 21 Days Drug 4 cycles Dose Admin 2 Day 1 Cisplatin 60mg/m Days 1 to 14 Capecitabine 1000mg/m BD 2 IV infusion over 90 minutes Twice daily (morning and evening) orally, for 14 days followed by 7 days off NB see capecitabine renal function recommendations and cisplatin hydration details see chapter one Laboratory investigations Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 45 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No: Mitomycin C / Fluoropyrimidine Mitomycin C and Fluorouracil Frequency Course length Every 42 days 4 cycles Drug Dose Admin 2 Day 1 Mitomycin C 7mg/m Days 1 to 4 Fluorouracil 1000mg/m daily Days 22 to 25 Fluorouracil 1000mg/m daily IV bolus 2 IV infusion over 24 hours 2 IV infusion over 24 hours OR Mitomycin C and Capecitabine Frequency Course length Five week course Drug One course Dose Admin 2 IV bolus 2 Twice daily (morning and evening) orally for 14 days followed by 7 days off Twice daily (morning and evening) orally for 14 days followed by 7 days off Day 1 Mitomycin C 7mg/m Days 1 to 14 Capecitabine 1000mg/m BD Days 22 to 35 Capecitabine 1000mg/m BD 2 NB see capecitabine renal function recommendations see chapter one Laboratory Investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply Issue Date: March 2014 Page 46 of 46 Issue No: 11.3.0 Author: Helen Flint Authorised by: Dr Haylock and Dr Moss Copy No:
