Hematology Oncology, P.C./Bennett Cancer Center

Open Protocols Hematology Oncology, P.C./Bennett Cancer Center

Primary Disease Stage Protocol Title Anemia See Pulmonary/Lung section: (Chemo Induced) Celgene ACE-011-NSCL-001 Breast Met. Breast ACORN ALSSMBC0804 Phase I/II Trial of Dasatinib plus Ixabepilone in 2nd or 3rd Line Metastatic Dr. Weinstein Breast Cancer Mary Breast Locally CALGB 40503 “A Randomized Phase III Trial of Endocrine Therapy Alone or Endocrine Advance Dr. Lo Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with d or Mary Hormone Receptor-Positive Advanced Breast Cancer” Metastati c ECOG N063D ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Dr. Del Prete Study: A Randomised, Multi-centre, Open-label, Phase III Study of Breast Adjuvant Mary Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Genentech TDM4370g Locally Adv. Safety of Trastuzumab-MCC-DM1 Vs. Capecitabine + Lapatinib in Patients Breast Dr. Lo Or Met. with HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Mary Have Received Prior Trastuzumab-Based Therapy A Randomized, Open-Label, Phase III Study of Taxane Based GSK EGF108919 Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Breast Stage IV Dr. Weinstein Women with HER2/neu Positive Metastatic Breast Cancer (The ‘Complete’ Mary Trial) NCIC MA.32 A Phase III Randomized Trial of Metformin versus Placebo on Recurrence Breast Adjuvant Dr. Angevine and Survival in Early Stage Breast Cancer Mary NSABP B-43 “A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently Breast Dr. Tepler with Radiation Therapy and Radiation Therapy Alone for Women with Mary/Ed HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy” Breast Wyeth 3144A2-3004-WW A Randomized Double-Blind Placebo-Controlled Trial of Neratinib (HKI- Dr. Weinstein 272) After Trastuzumab in Women with Early-Stage HER2/NEU Mary Overexpressed/Amplified Breast Cancer

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Primary Disease Stage Protocol Title

ACORN ARCHESO0611 A Phase III Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin Digestive System/GI Dr. Del Prete and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Ed Gastroesophageal Adenocarcinoma CALGB 90601 A Randomized Doubled-Blinded Phase III Study Comparing Gemcitabine, Genitourinary/GU Metastatic Dr. Cohen Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Bladder Ed Patients with Advanced Transitional Cell Carcinoma A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Amgen 20060517 GYN Doxorubicin (PLD) Plus AMG 386 or Placebo in Women with Recurrent Dr. Del Prete Ovarian partially Pltinum Sensitive or Resistant Epithelial Ovarian, Primary Sue Peritoneal, or Fallopian Tube Cancer (TRINOVA-2) GOG-0252 A Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy GYN II & III Dr. Del Prete in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma Ovarian Sue A Randomized Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose GOG-0262 Dense Weekly Paclitaxel in Combination with Carboplatin with or without GYN III & IV Dr. Del Prete Concurrent and Consolidation Bevacizumab (NSC #704865, IND #7921) in Ovarian Sue the Treatment of Primary Stage III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess Morphotek MORAb-003-004 GYN the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in III & IV Dr. Del Prete Ovarian Combination with Carboplatin and Taxane in Subjects with Platinum- Sue sensitive Ovarian Cancer in First Relapse A Phase III Open Label, Randomized, 2 Arm Study of Ixabepilone Bristol-Myers CA163196 GYN Administered Every 21 Days Versus Paclitaxel or Doxurubicin Relapsed Met. Dr. Del Prete Uterine Administered Every 21 Days in Women with Endometrial Cancer Who Sue Have Previously Been Treated with Chemotherapy A Randomized Phase III Trial of Paclitaxel Plus Carboplatin versus GOG-0261 GYN Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients with Newly I-IV Dr.Del Prete Uterus Diagnosed Stage I-IV Persistent or Recurrent Carcinosarcoma (Mixed Sue Mesodermal Tumors) of the Uterus Hematologic Celgene Connect CLL Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry Malignancy Dr. Bar

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Primary Disease Stage Protocol Title Sue A Randomized Multicenter Study Comparing Pixantrone + Rituximab with Cell Therapeutics PIX306 Diffuse Large Gemcitabine + Rituximab in Patients with Aggressive B-Cell Non- Lymphoma Dr. Angevine B-Cell Hodgkin’s Lymphoma Who Have Relapsed after Therapy with CHOP-R or Sue an Equivalent Regimen and are Ineligible for Stem Cell Transplant Celgene CONNECT MM Connect™ MM: The Multiple Myeloma Disease Registry Multiple Myeloma Dr. Bar Sue Novartis CLBH589D2308 A multicenter, randomized, double-blind, placebo-controlled phase III study of panobinostat in combination with Bortezomib and Dexamethasone in Multiple Myeloma Relapsed Dr. Bar patients with relapsed multiple myeloma Sue Multiple Tumors A Phase I Dose Escalation Study of MLN8237, an Aurora A Kinase Millennium C14007 Lung, Breast, Head & Inhibitor, in Adult Patients With Nonhematological Malignancies, Followed Dr. Del Prete Neck, by a Phase 2 of MLN8237 in Lung, Breast, Head and Neck, or Mary Gastroesophageal Malignancies Gastroesophageal A Single-Blind, Randomized, Phase 2A, Dose Ranging Study (Part 1) of Celgene ACE-011-NSCL-001 Sotatercept (ACE-011) Therapy Followed by a Phase 2B/3 Double-Blind, Pulmonary/Lung Randomized, Placebo-Controlled Study (Part 2) of Sotatercept (ACE-011) Metastatic Dr. Del Prete NSCLC for Chemotherapy Induced Anemia in Subjects with Metastatic Non-Small Ed Cell Lung Cancer Treated with First-line Platinum-Based Chemotherapeutic Regimens ECOG 1505 A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Pulmonary/Lung Adjuvant Dr. Del Prete Bevacizumab for Patients with Completely Resected Stage IB (≥ 4cm) – IIA NSCLC IB-IIIA Ed Non-Small Cell Lung Cancer (NSCLC) Locally A Randomized Phase 2 Study of a Human Anti-PDGFRa Antibody ImClone CP15-0804 Pulmonary/Lung Advanced or (IMC-3G3) with Paclitaxel/Carboplatin or Paclitaxel/Carboplatin Alone in Dr. Weinstein NSCLC Met. Previously Untreated Patients with Locally Advanced or Metastatic Non- Ed Stage III/IV Small Cell Lung Cancer A Randomized, Double-Blind, Placebo-controlled, Study of the Safety and Morphotek MORAb-003-009 Pulmonary/Lung Efficacy of Farletuzumab in Combination with Carboplatin and Paclitaxel or Stage IV Dr. Del Prete NSCLC Docetaxel Follow by Pemetrexed in Chemotherapy-naive Subjects with Ed Stage IV Adenocarcinoma of the Lung with Wild Type EGFR.

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