Protocol

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Open Protocols
Stamford Hospital/Medical Oncology Hematology Research
Primary
Breast
Disease Stage
Adjuvant
Breast
Adjuvant
Digestive/GI
Colon
Adjuvant
Digestive/GI
Colorectal
Protocol
NCIC MA.32
Dr. Angevine
Mary Miller, LPN
NSABP B-49
Dr. Weinstein
Mary Miller, LPN
NSABP P-5
Dr. Del Prete
Ed Hatton, RN
Genentech ML25710
Dr. Del Prete
Ed Hatton, RN
Title
A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and
Survival in Early Stage Breast Cancer
A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus
Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women
with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Statin Polyp Prevention Trial in Patients with Resected Colon Cancer
A Randomized Phase II Study of Bevacizumab/mFOLFOX6 vs.
Bevacizumab/FOLFIRI with Biomarker Stratification in Patients with Previously
Untreated Metastatic Colorectal Cancer (MAVERICC)
Digestive/GI
Colorectal
Gilead GS-US-205-0203
Dr. Del Prete
Ed Hatton, RN
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the
Efficacy and Safety of GS-6624 Combined with FOLFIRI as Second Line
Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma that has
Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing
Regimen
Digestive/GI
Colorectal
Metastatic
NCCTG N0949
Dr. Del Prete
Ed Hatton, RN
Randomized Phase III Trial of mFOLFOX7 or XELOX Plus Bevacizumab Versus
5-Fluorouracil/Leucovorin or Capecitabine Plus Bevacizumab as First-line
Treatment in Elderly Patients with Metastatic Colorectal Cancer
Digestive/GI
Pancreatic
Metastatic
Gilead GS-US-324-0101
Dr. Del Prete
Ed Hatton, RN
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the
Efficacy and Safety of GS-6624 Combined with Gemcitabine as First Line
Treatment for Metastatic Pancreatic Adenocarcinoma
Digestive/GI
Pancreatic
Recurrent or
Metastatic
INCYTE INCB 18424-262
Dr. Del Prete
Ed Hatton, RN
A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination
with CApecitabine for Subjects with recurrent or Treatment Refractory Metastatic
Pancreatic Cancer (The RECAP trial)
Digestive/GI
Pancreatic
Adjuvant Stage
I or II
Resected R0 or
R1
NewLink NLG-0405
Dr. Del Prete
Ed Hatton, RN
Metastatic
CALGB 90601
Dr. Cohen
Ed Hatton, RN
Genitourinary/GU
Bladder
A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without
HyperAcute®-Pancreas (algenpantucel-L) Immunotherapy is Subjects with
Surgically Resected Pancreatic 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
D:\533569943.doc 11JAN12, 2FEB12, 20Feb12; 8MAR12, 22MAY12, 24MAY12, 4JUN12, 7JUN12
Copy to: C: Builes, C. Di Bona, D. Derdelinghen, L. Manfredo, , K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson
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Open Protocols
Stamford Hospital/Medical Oncology Hematology Research
Primary
Disease Stage
Protocol
Genitourinary/GU
Prostate
Dendron P10-3
Dr. Cohen
Mary Miller, LPN
Genitourinary/GU
Prostate
Sanofi-Aventis EFC11784
Dr. Cohen
Ed Hatton, RN
Genitournary/GU
Prostate
Sanofi-Aventis EFC11785
Dr. Cohen
Ed Hatton, RN
Genitourinary/GU
Renal
Metastatic
GYN - Ovarian, Primary
Peritoneal, or Fallopian
Tube Cancers
GYN
Ovarian
CALGB 90802
Dr. Del Prete
Sue Murdock, RN
Amgen 20101129
Dr. Del Prete
Sue Murdock, RN
II-IV or
recurrent stage
I
GOG-0241
Dr.Del Prete
Sue Murdock, RN
GYN
Ovarian
Merrimack MM-121-04-02-08
Dr. Del Prete
Sue Murdock, RN
GYN
Uterus
GOG-0261
Dr.Del Prete
Sue Murdock, RN
I-IV
Title
A Registry of Sipuleucel-T® Therapy in Men with Advanced Prostate Cancer
(PROCEED)
Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2
and at 20 mg/m2 in combination with Prednisone Every 3 Weeks to Docetaxel in
Combination with Prednisone in Patients with Metastatic Castration Resistant
Prostate Cancer not Pretreated with Chemotherapy (Study Name: FIRSTANA)
Randomized, Open-Label Multi-Center Study comparing Cabazitaxel at 20 mg/m2
and at 25 mg/m2 Every 3 Weeks in Combination with Prednisone for the Treatment
of Metastatic Castration Resistant Prostate Cancer Previously Treated with a
Docetaxel-Containing Regimen (Study Name: PROSELICA)
Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus
Everolimus Plus Bevacizumab For Advanced Renal Cell Carcinoma Progressing
After Treatment With Tyrosine Kinase Inhibitors
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of
AMG 386 with Paclitaxel and Carboplatin as First-line Treatment of Subjects with
Figo Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
(TRINOVA-3)
A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and
Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865, IND #113912)
Compared with Oxaliplatin and Capecitabine +/- Bevacizumab as First Line
Chemotherapy in Patients with Mucinous Epithelial Ovarian or Fallopian Tube
Cancer (MEOC)
A Phase II Randomized Open Label Study of MM-121 in Combination with
Paclitaxel Versus Paclitaxel Alone in Patients with Platinum Resistant/Refractory
Advanced Ovarian Cancers
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
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
Celgene Connect CLL
Dr. Bar
Sue Murdock, RN
Hematologic
Malignancy
Lymphoma
Diffuse Large
Cell Therapeutics PIX306
A Randomized Multicenter Study Comparing Pixantrone + Rituximab with
D:\533569943.doc 11JAN12, 2FEB12, 20Feb12; 8MAR12, 22MAY12, 24MAY12, 4JUN12, 7JUN12
Copy to: C: Builes, C. Di Bona, D. Derdelinghen, L. Manfredo, , K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson
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Open Protocols
Stamford Hospital/Medical Oncology Hematology Research
Primary
Disease Stage
Protocol
B-Cell
Dr. Angevine
Sue Murdock, RN
Gemcitabine + Rituximab in Patients with Aggressive B-Cell Non-Hodgkin’s
Lymphoma Who Have Relapsed after Therapy with CHOP-R or an Equivalent
Regimen and are Ineligible for Stem Cell Transplant
MMRF-11-001
Dr. Bar
Sue Murdock, RN
A Prospective, Longitudinal, Observational Study in Newly Diagnosed Multiple
Myeloma (MM) Patients to Assess the Relationship between Patient Outcomes,
Treatment Regimens and Molecular Profiles (CoMMpass)
Multiple Myeloma
Pulmonary/Lung
NSCLC
Adjuvant
IB-IIIA
Genentech GO27912
Pulmonary/Lung
NSCLC
Dr. Del Prete
Ed Hatton, RN
Pulmonary/Lung
Melanoma
ECOG 1505
Dr. Del Prete
Ed Hatton, RN
Stage III/IV
Millennium C14007
Dr. Del Prete
Mary Miller, LPN
E1609
Dr. Del Prete
Ed Hatton, RN
Title
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without
Bevacizumab for Patients with Completely Resected Stage IB (≥ 4cm) – IIA NonSmall Cell Lung Cancer (NSCLC)
A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the
Safety and Efficacy of Carboplatin/Paclitaxel and
Carboplatin/Paclitaxel/Bevacizumab with and without GDC-0941 in Patients with
Previously Untreated Advanced or Recurrent Non-Small Cell Lung Cancer
A Phase I Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in
Adult Patients With Non-hematological Malignancies, Followed by a Phase 2 of
MLN8237 in Lung, Breast, Head and Neck, or Gastroesophageal Malignancies
A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy
versus High-Dose Interferon α-2b for Resected High-Risk Melanoma
D:\533569943.doc 11JAN12, 2FEB12, 20Feb12; 8MAR12, 22MAY12, 24MAY12, 4JUN12, 7JUN12
Copy to: C: Builes, C. Di Bona, D. Derdelinghen, L. Manfredo, , K. Radziewicz, M. Ronk, D. Sardanovic, E. Johnson
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