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Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Anemia
(Chemo Induced)
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)
Breast
NSABP B-43
Dr. Tepler
Mary/Ed
Breast
Wyeth 3144A2-3004-WW
Dr. Weinstein
Mary
Digestive System/GI
Gastroesophageal
ACORN ARCHESO0611
Dr. Del prete
Ed
“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
A Phase III Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin
and Continuous Infusion 5FU in the Treatment of Potentially Resectable
Gastroesophageal Adenocarcinoma
D:\840947351.doc Revised 3JAN11, 13JAN11, 14FEB11; 10MAR11; 22MAR11; 23MAR11; 19MAY11 ; 23May11; 6JUN11; 22JUN11; &JUL11
Copy to D. Derdelinghen, L. Manfredo, C. Pagie, K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson
Page 1
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Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Disease Stage
Keryx Perifosine 343
Dr. Weinstein
Ed
Digestive System/GI
Colorectal
Genitourinary/GU
Bladder
Protocol
Metastatic
CALGB 90601
Dr. Cohen
Ed
GYN
Ovarian
Amgen 20060517
Dr. Del Prete
Sue
GYN
Ovarian
III & IV
Morphotek MORAb-003-004
Dr.Del Prete
Sue
II & III
GOG-0252
Dr. Del Prete
Sue
GYN
Ovarian
GYN
Ovarian
GYN
Uterine
GYN
Uterus
III & IV
GOG-0262
Dr. Del Prete
Sue
Relapsed Met.
Bristol-Myers CA163196
Dr. Del Prete
Sue
I-IV
GOG-0261
Dr.Del Prete
Sue
Title
A Phase III Randomized Double-Blind Study to Assess the Efficacy and
Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in
Patients with Refractory Advanced Colorectal Cancer
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 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
A Phase III Clinical Trial of Bevacizumab with IV versus IP Chemotherapy
in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
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
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
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
D:\840947351.doc Revised 3JAN11, 13JAN11, 14FEB11; 10MAR11; 22MAR11; 23MAR11; 19MAY11 ; 23May11; 6JUN11; 22JUN11; &JUL11
Copy to D. Derdelinghen, L. Manfredo, C. Pagie, K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson
Page 2
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Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Disease Stage
Hematologic
Malignancy
Hematologic
Malignancy
Multiple Myeloma
Multiple Myeloma
Relapsed
Multiple Tumors
Lung, Breast, Head &
Neck,
Gastroesophageal
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
Protocol
Celgene Connect CLL
Dr. Bar
Sue
Novartis CICL670AUS38
Dr. Bar
Ed
Celgene CONNECT MM
Dr. Bar
Sue
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
Novartis CLBH589D2308
Dr. Bar
Sue
A multicenter, randomized, double-blind, placebo-controlled phase III study
of panobinostat in combination with Bortezomib and Dexamethasone in
patients with relapsed multiple myeloma
Millennium C14007
Dr. Del Prete
Mary
Metastatic
Celgene ACE-011-NSCL-001
Adjuvant
IB-IIIA
E1505
Dr. Del Prete
Ed
Locally
Advanced or
Met.
Stage III/IV
Title
ImClone CP15-0804
Dr. Weinstein
Ed
A 5-Year, Prospective, Non-Interventional Registry in Sickle Cell Disease
Patients
Connect™ MM: The Multiple Myeloma Disease Registry
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
D:\840947351.doc Revised 3JAN11, 13JAN11, 14FEB11; 10MAR11; 22MAR11; 23MAR11; 19MAY11 ; 23May11; 6JUN11; 22JUN11; &JUL11
Copy to D. Derdelinghen, L. Manfredo, C. Pagie, K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson
Page 3
of 3