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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
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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
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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
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