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Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Breast
Breast
Breast
Breast
Breast
Disease Stage
Locally
Advanced or
Metastatic
Met or locally
advanced
Protocol
ACORN AC01B07
PW - Mary
Amgen 20060341
PW – Mary
“A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to
Placebo When Administered in Combination with Chemotherapy for
Patients with Locally Advanced or Metastatic Breast Cancer that has
Progressed During or After Bevacizumab Therapy”
“A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in
Combination with Bevacizumab and Paclitaxel or AMG 386 plus Paclitaxel
as First-Line Therapy in Subjects with Her2-Negative, Metastatic or Locally
Recurrent Breast Cancer”
“An International, Randomized, Double-blind, Placebo-Controlled, Phase 2
Study of AMG 479 with Exemestance or Fulvestrant in Postmenopausal
Women with Hormone Receptor Positive Locally Advanced or Metastatic
Breast Cancer”
Hormone
Receptor Positive
Locally
Advanced or
Met.
Amgen 20070362
PW - Mary
I-II
ECOG 5103
DP - Mary
“A Double-Blind III Trial of Doxorubicin and Cyclophosphamide followed
by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node
Positive and High-risk Lymph Node Negative Breast Cancer”
ECOG N063D
DP – Mary
(suspended as of 06/13/08)
ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation
Study: A Randomised, Multi-centre, Open-label, Phase III Study of
Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination
in Patients with HER2/ErbB2 Positive Primary Breast Cancer
“Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial
Assigning Individualized Options for Treatment: The Tailorx Trial” (Phase
III)
Adjuvant
Breast
Adjuvant
Stage I-II with
negative lymph
nodes
ECOG PACCT-1
PW - Mary
Breast
Observational
Genentech AVF4349n
Breast
Title
III
IBCSG 24-02
SOFT
IT - Kathy
“An Observational Study of Treatment Patterns and Safety Outcomes for
Metastatic or Locally Recurrent Breast Cancer (VIRGO)”
“A Phase III Trial Evaluating the Role of Ovarian Function Suppression and
the Role of Exemestane as Adjuvant Therapies for Premenopausal Women
with Endocrine Responsive Breast Cancer”
D:\769817748.doc Revised 6FEB08; 4MAR08; 1APR08; 8APR08; 22APR08; 6MAY08; 8MAY08; 27MAY08; 26JUN08; 1JUL08; 2JUL08; 22JUL08; 31JUL08; 25AUG08; 2SEP08
Page 1 of 5
Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Breast
Breast
Digestive
System/GI
Colorectal
Digestive
System/GI
Colon or Rectum
Digestive
Systems/GI
Disease Stage
I-IIIA
Adjuvant
II/III
Metastatic
IV
III
Colon
Digestive
System/GI
Colon
Digestive
System/GI
Rectal
Protocol
Title
NSABP B-42
PW - Mary
“A Clinical Trial to Determine the Efficacy of Five Years of Letrozole
Compared to Placebo in Patients Completing Five Years of Hormonal
Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed
by an AI in Prolonging Disease-Free Survival in Postmenopausal Women
with Hormone Receptor Positive Breast Cancer” (Phase III)
Roche BO20289
PW - Mary
AstraZeneca D848C00013
HORIZON III
DP - Ed
A Randomized, Double-blind, Multicentre Phase II/III Study to Compare
the Efficacy of Dediranib (RECENTIN, AZD2171) in Combination with 5Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of
Bevacizumab in Combination with FOLFOX in Patients with Previously
Untreated Metastatic Colorectal Cancer
CALGB 80405
DP – Ed
“A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin
with Bevacizumab, or Cetuximab (C225), or with the Combination of
Bevacizumab and Cetuximab for Patients with Untreated Metastatic
Adenocarcinoma of the Colon or Rectum”
(suspended as of 06/06/08)
NCCTG N0147
DP – Ed
(suspended as of 06/06/08)
II
II or III
An International Multi-Centre Open-Label 2 Arm Phase III Trial of
Adjuvant Bevacizumab in Triple Negative Breast Cancer And Roche
Sample Repository Research Project in Association with Protocol BO20289
E5202
DP – Ed
E5204
DP – Ed
“A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil
(5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative
Resection for Patients with Stage III Colon Cancer”
“A Randomized Phase III Study Comparing 5-FU, Leucovorin and
Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in
Patients with Stage II Colon Cancer at High Risk for Recurrence to
Determine Prospectively the Prognostic Value of Molecular Markers”
“Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and
Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation”
D:\769817748.doc Revised 6FEB08; 4MAR08; 1APR08; 8APR08; 22APR08; 6MAY08; 8MAY08; 27MAY08; 26JUN08; 1JUL08; 2JUL08; 22JUL08; 31JUL08; 25AUG08; 2SEP08
Page 2 of 5
Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Digestive
System/GI
Pancreas
Digestive
System/GI
Pancreas
Genitourinary/GU
Kidney
Genitourinary/GU
Urothelial Tract or
Bladder
Genitourinary/GU
Prostate
GYN
Ovarian, Fallopian
or Primary
Peritoneal CA
Disease Stage
Protocol
Imclone CP02-0555
DP – Ed
IV
Metastatic
Temporarily closed to accrual
3/6/08 for scheduled review
of safety data.
Sanofi-Aventis EFC10203
DP/Ed
Title
“A Phase II, Randomized, Open-Label Study of Cetuximab and
Bevacizumab Alone or in Combination with Fixed-Dose Rate Gemcitabine
as First-Line Therapy of Patients with Metastatic Adenocarcinoma of the
Pancreas”
“A Multicenter, Open-Label, Randomized Study Comparing the Efficacy
and Safety of S-1 as a Single Agent at 30 mg/M2 BID Versus 5-FU Bolus
Infusion for the Treatment of Patients with Metastatic Pancreatic Cancer
Previously Treated with a Gemcitabine-Based Regimen”
Amgen 20060159
DP – Sue
A Randomized, Double Blinded, Multicenter Phase 2 Study to Estimate the
Efficacy and Evaluate the Safety and Tolerability of Sorafenib in
Combination with AMG 386 or Placebo in Subjects with Metastatic Clear
Cell Carcinoma of the Kidney
Advanced or
Metastatic
Sanofi-Aventis EFC 6668
NC - Ed
Randomized Study of Larotaxel + Cisplatin vs Gemzar + Cisplatin in 1st
Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder
Cancer”
Metastatic
COUGAR COU-AA-301
NC - Kathy
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of
Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic
Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based
Chemotherapy
IV lower
intermediate risk
Advanced
Covance NV06-0039
DP – Sue
Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study
Comparing Phenoxodiol (Oral Dosage Form) in Combination with
Carboplatin versus Carboplatin with Placebo in Patients with PlatinumResistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian
or Primary Peritoneal Cancer Following at Least Second Line Platinum
Therapy
D:\769817748.doc Revised 6FEB08; 4MAR08; 1APR08; 8APR08; 22APR08; 6MAY08; 8MAY08; 27MAY08; 26JUN08; 1JUL08; 2JUL08; 22JUL08; 31JUL08; 25AUG08; 2SEP08
Page 3 of 5
Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
GYN
Ovary, Peritoneal,
Fallopian Tube
GYN
Ovarian, Primary
Peritoneal
Multiple Myeloma
Multiple Site
NSCLC, Breast
(The CRC portion
closed to accrual
1/24/08)
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
Disease Stage
Protocol
Title
Advanced
Genentech AVF4095g
OCEANS
DP – Sue
“A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of
Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinumsensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube
Carcinoma”
Advanced
Advanced
GOG 0218
DP – Sue
Millennium C05008
MB - Sue
“A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus
Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865,
IND #7921) Followed by Placebo, versus Carboplatin and Paclitaxel Plus
Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed,
Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and
Primary Peritoneal Cancer “
“A Phase I/II Study of VELCADE (Bortezomib), Dexamethasone, and
Revlimid (Lenalidomide) (VDR) versus VELCADE, Dexamethasone,
Cyclophosphamide, and Revlimid (VDR) in Subjects with Previously
Untreated Multiple Myeloma”
IV
Genentech AVF3991n
ARIES
DP - Ed
IIIA/B
Dartmouth Hitchcock D0410
DP - Ed
“An Observational Study of Avastin (Bevacizumab) in Combination with
Chemotherapy for Treatment of Metastatic or Locally Advanced and
Unresectable Colorectal Cancer, Locally Advanced or Metastatic Non-Small
Cell Lung (Excluding Predominant Squamous Cell Histology), or Locally
Recurrent or Metastatic Breast Cancer”
Note: Only Open for 2nd line colon cancer.
“A National Web-Based Randomized Phase III Study of Erlotinib or
Placebo Following concurrent Docetaxel, Carboplatin and Thoracic
Radiotherapy in Patients with Inoperable Stage III Non-Small Cell Lung
Cancer”
E1505
DP - Ed
“A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without
Bevacizumab for Patients with Completely Resected Stage IB (≥ 4cm) – IIIA NonSmall Cell Lung Cancer (NSCLC)”
ImClone CP02-0452
PW - KD
Randomized Phase III Study of Docetaxel or Pemetrexed with or without
Cetuximab in Patients with Recurrent or Progressive Non-Small Cell Lung
Cancer after Platinum-Based Therapy
Adjuvant
IB-IIIA
IIIB, IV
D:\769817748.doc Revised 6FEB08; 4MAR08; 1APR08; 8APR08; 22APR08; 6MAY08; 8MAY08; 27MAY08; 26JUN08; 1JUL08; 2JUL08; 22JUL08; 31JUL08; 25AUG08; 2SEP08
Page 4 of 5
Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
Skin Cancer
Melanoma
Melanoma
Disease Stage
Protocol
Observational
Lilly H3E-US-B001
DP -Mary
IB-IIIA
OSI-774-302
RADIANT
DP - Kathy
T3 – T4 or N1
Stage IV
Metastatic
E1697
DP - Mary
SYNTA 4783-08
SYMMETRY
SD – Ed
Title
“Non-Small Cell Lung Cancer: The Impact of Ethnic Origin on Patients being
Treated Second Line with Pemetrexed – an Observational Study”
“A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 3
Study of Single-agent Tarceva (erlotinib) Following Complete Tumor
Resection with or without Adjuvant Chemotherapy in Patients with Stage
IB-IIIA Non-Small Cell Lung Carcinoma who have EGF-positive Tumors”
“A Phase III Randomized Study of Four Weeks High Dose IFN-a2b in
Stage T2b N0, T3a-b, T4a-b N0, and T1-4, N1a, 2a, 3 (microscopic) Melanoma.”
“A Randomized, Double-blind, Phase 3 Trial of STA-4783 in Combination
with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy
Naïve Subjects with Stage IV Metastatic Melanoma (SYMMETRY)”
D:\769817748.doc Revised 6FEB08; 4MAR08; 1APR08; 8APR08; 22APR08; 6MAY08; 8MAY08; 27MAY08; 26JUN08; 1JUL08; 2JUL08; 22JUL08; 31JUL08; 25AUG08; 2SEP08
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