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Open Protocols Hematology Oncology, P.C./Bennett Cancer Center Primary Anemia (Chemo Induced) Breast Breast Breast Breast Breast Breast Breast Breast Disease Stage Met. Breast Locally Advanced or Metastatic Adjuvant Protocol See Pulmonary/Lung section: Celgene ACE-011-NSCL-001 ACORN ALSSMBC0804 Dr. Weinstein Mary CALGB 40503 Dr. Lo Mary ECOG N063D Dr. Del Prete Mary Title Phase I/II Trial of Dasatinib plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer “A Randomized Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptor-Positive Advanced Breast Cancer” 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 Locally Adv. Or Met. Genentech TDM4370g Dr. Lo Mary A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 Vs. Capecitabine + Lapatinib in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy Stage IV GSK EGF108919 Dr. Weinstein Mary A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer (The ‘Complete’ Trial) Adjuvant NCIC MA.32 Dr. Angevine Mary NSABP B-43 Dr. Tepler Mary/Ed Wyeth 3144A2-3004-WW Dr. Weinstein Mary A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer “A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy” A Randomized Double-Blind Placebo-Controlled Trial of Neratinib (HKI272) After Trastuzumab in Women with Early-Stage HER2/NEU Overexpressed/Amplified Breast Cancer D:\840959730.doc Revised 3JAN11, 13JAN11, 14FEB11; 10MAR11; 22MAR11; 23MAR11; 19MAY11 ; 23May11; 6JUN11; 22JUN11; &JUL11; 25JUL11; 3AUG11 ; 22AUG11 Copy to D. Derdelinghen, L. Manfredo, C. Pagie, K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson Page 1 of 3 Open Protocols Hematology Oncology, P.C./Bennett Cancer Center Primary Disease Stage Digestive System/GI Gastroesophageal Genitourinary/GU Bladder Metastatic Protocol ACORN ARCHESO0611 Dr. Del Prete Ed CALGB 90601 Dr. Cohen Ed GYN Ovarian Amgen 20060517 Dr. Del Prete Sue GYN Ovarian GOG-0252 Dr. Del Prete Sue GYN Ovarian GYN Ovarian GYN Uterine GYN Uterus Hematologic Malignancy II & III Title A Phase III Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma A Randomized Doubled-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women with Recurrent partially Pltinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (TRINOVA-2) A Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma III & IV GOG-0262 Dr. Del Prete Sue A Randomized Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination with Carboplatin with or without Concurrent and Consolidation Bevacizumab (NSC #704865, IND #7921) in the Treatment of Primary Stage III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer III & IV Morphotek MORAb-003-004 Dr. Del Prete Sue A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinumsensitive Ovarian Cancer in First Relapse Relapsed Met. Bristol-Myers CA163196 Dr. Del Prete Sue A Phase III Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxurubicin Administered Every 21 Days in Women with Endometrial Cancer Who Have Previously Been Treated with Chemotherapy I-IV GOG-0261 Dr.Del Prete Sue A Randomized Phase III Trial of Paclitaxel Plus Carboplatin versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus Celgene Connect CLL Dr. Bar Sue Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry D:\840959730.doc Revised 3JAN11, 13JAN11, 14FEB11; 10MAR11; 22MAR11; 23MAR11; 19MAY11 ; 23May11; 6JUN11; 22JUN11; &JUL11; 25JUL11; 3AUG11 ; 22AUG11 Copy to D. Derdelinghen, L. Manfredo, C. Pagie, K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson Page 2 of 3 Open Protocols Hematology Oncology, P.C./Bennett Cancer Center Primary Lymphoma Disease Stage Protocol Title Diffuse Large B-Cell Cell Therapeutics PIX306 Dr. Angevine Sue A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in Patients with Aggressive B-Cell NonHodgkin’s Lymphoma Who Have Relapsed after Therapy with CHOP-R or an Equivalent Regimen and are Ineligible for Stem Cell Transplant Multiple Myeloma Celgene CONNECT MM Dr. Bar Sue Multiple Myeloma Novartis CLBH589D2308 Dr. Bar Sue Relapsed Multiple Tumors Lung, Breast, Head & Neck, Gastroesophageal Pulmonary/Lung NSCLC Pulmonary/Lung NSCLC Pulmonary/Lung NSCLC Pulmonary/Lung NSCLC Millennium C14007 Dr. Del Prete Mary Metastatic Adjuvant IB-IIIA Celgene ACE-011-NSCL-001 Dr. Del Prete Ed ECOG 1505 Dr. Del Prete Ed Locally Advanced or Met. Stage III/IV ImClone CP15-0804 Dr. Weinstein Ed Stage IV Morphotek MORAb-003-009 Dr. Del Prete Ed Connect™ MM: The Multiple Myeloma Disease Registry A multicenter, randomized, double-blind, placebo-controlled phase III study of panobinostat in combination with Bortezomib and Dexamethasone in patients with relapsed multiple myeloma A Phase I Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in Adult Patients With Nonhematological Malignancies, Followed by a Phase 2 of MLN8237 in Lung, Breast, Head and Neck, or Gastroesophageal Malignancies A Single-Blind, Randomized, Phase 2A, Dose Ranging Study (Part 1) of Sotatercept (ACE-011) Therapy Followed by a Phase 2B/3 Double-Blind, Randomized, Placebo-Controlled Study (Part 2) of Sotatercept (ACE-011) for Chemotherapy Induced Anemia in Subjects with Metastatic Non-Small Cell Lung Cancer Treated with First-line Platinum-Based Chemotherapeutic Regimens A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients with Completely Resected Stage IB (≥ 4cm) – IIA Non-Small Cell Lung Cancer (NSCLC) A Randomized Phase 2 Study of a Human Anti-PDGFRa Antibody (IMC-3G3) with Paclitaxel/Carboplatin or Paclitaxel/Carboplatin Alone in Previously Untreated Patients with Locally Advanced or Metastatic NonSmall Cell Lung Cancer A Randomized, Double-Blind, Placebo-controlled, Study of the Safety and Efficacy of Farletuzumab in Combination with Carboplatin and Paclitaxel or Docetaxel Follow by Pemetrexed in Chemotherapy-naive Subjects with Stage IV Adenocarcinoma of the Lung with Wild Type EGFR. D:\840959730.doc Revised 3JAN11, 13JAN11, 14FEB11; 10MAR11; 22MAR11; 23MAR11; 19MAY11 ; 23May11; 6JUN11; 22JUN11; &JUL11; 25JUL11; 3AUG11 ; 22AUG11 Copy to D. Derdelinghen, L. Manfredo, C. Pagie, K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson Page 3 of 3