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Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Breast
Breast
Breast
Adjuvant
Breast
Breast
Digestive
System/GI
Colon or Rectum
Disease Stage
Protocol
Title
Amgen 20060341
PW – Mary
“A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in
Combination with Bevacizumab and Paclitaxel or AMG 386 plus Paclitaxel
as First-Line Therapy in Subjects with Her2-Negative, Metastatic or Locally
Recurrent Breast Cancer”
I-II
ECOG 5103
DP - Mary
“A Double-Blind III Trial of Doxorubicin and Cyclophosphamide followed
by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node
Positive and High-risk Lymph Node Negative Breast Cancer”
Stage I-II with
negative lymph
nodes
ECOG PACCT-1
PW - Mary
“Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial
Assigning Individualized Options for Treatment: The Tailorx Trial” (Phase
III)
IBCSG 24-02
SOFT
IT - Kathy
“A Phase III Trial Evaluating the Role of Ovarian Function Suppression and
the Role of Exemestane as Adjuvant Therapies for Premenopausal Women
with Endocrine Responsive Breast Cancer”
NSABP B-42
PW - Mary
“A Clinical Trial to Determine the Efficacy of Five Years of Letrozole
Compared to Placebo in Patients Completing Five Years of Hormonal
Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed
by an AI in Prolonging Disease-Free Survival in Postmenopausal Women
with Hormone Receptor Positive Breast Cancer” (Phase III)
Met or locally
advanced
III
I-IIIA
IV
Digestive
Systems/GI
Colon
Digestive
System/GI
Colon
CALGB 80405
DP - Ed
NCCTG N0147
III
II
DP – Ed
E5202
DP – Ed
D:\582759935.doc Revised 6FEB2008; 4MAR2008; 1APR2008; 8APR2008; 22APR2008
“A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin
with Bevacizumab, or Cetuximab (C225), or with the Combination of
Bevacizumab and Cetuximab for Patients with Untreated Metastatic
Adenocarcinoma of the Colon or Rectum”
“A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil
(5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative
Resection for Patients with Stage III Colon Cancer”
“A Randomized Phase III Study Comparing 5-FU, Leucovorin and
Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in
Patients with Stage II Colon Cancer at High Risk for Recurrence to
Determine Prospectively the Prognostic Value of Molecular Markers”
Page 1
of 4
Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Digestive
System/GI
Rectal
Digestive
System/GI
Pancreas
Digestive
System/GI
Pancreas
Genitourinary/GU
Kidney
GYN
Ovarian, Fallopian
or Primary
Peritoneal CA
GYN
Ovary, Peritoneal,
Fallopian Tube
Disease Stage
II or III
Protocol
Title
E5204
DP – Ed
“Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and
Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation”
Imclone CP02-0555
DP – Ed
IV
Metastatic
IV lower
intermediate risk
Advanced
Advanced
Temporarily closed to accrual
3/6/08 for scheduled review
of safety data.
Sanofi-Aventis EFC10203
DP/Ed
“A Phase II, Randomized, Open-Label Study of Cetuximab and
Bevacizumab Alone or in Combination with Fixed-Dose Rate Gemcitabine
as First-Line Therapy of Patients with Metastatic Adenocarcinoma of the
Pancreas”
“A Multicenter, Open-Label, Randomized Study Comparing the Efficacy
and Safety of S-1 as a Single Agent at 30 mg/M2 BID Versus 5-FU Bolus
Infusion for the Treatment of Patients with Metastatic Pancreatic Cancer
Previously Treated with a Gemcitabine-Based Regimen”
Amgen 20060159
DP – Sue
A Randomized, Double Blinded, Multicenter Phase 2 Study to Estimate the
Efficacy and Evaluate the Safety and Tolerability of Sorafenib in
Combination with AMG 386 or Placebo in Subjects with Metastatic Clear
Cell Carcinoma of the Kidney
Covance NV06-0039
DP – Sue
Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study
Comparing Phenoxodiol (Oral Dosage Form) in Combination with
Carboplatin versus Carboplatin with Placebo in Patients with PlatinumResistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian
or Primary Peritoneal Cancer Following at Least Second Line Platinum
Therapy
Genentech AVF4095g
OCEANS
DP – Sue
“A Phase II, Multicenter, Randomized, Blinded, Placebo-controlled Trial of
Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinumsensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube
Carcinoma”
D:\582759935.doc Revised 6FEB2008; 4MAR2008; 1APR2008; 8APR2008; 22APR2008
Page 2
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Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
GYN
Ovarian, Primary
Peritoneal
Lymphoma
NHL
Advanced
Any
Multiple Myeloma
Multiple Site
NSCLC, Breast
(The CRC portion
closed to accrual
1/24/08)
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
IV
IIIB, IV
IIIA/B
Adjuvant
IB-IIIA
Observational
GOG 0218
DP – Sue
“A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus
Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865,
IND #7921) Followed by Placebo, versus Carboplatin and Paclitaxel Plus
Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed,
Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and
Primary Peritoneal Cancer “
J&J 26866138-LYM-3001
NC – Kathy
“A Randomized, Open-Label, Multicenter Study of VELCADE with
Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory,
Rituximab Naïve or Sensitive Follicular B-Cell Non-Hodgkin’s Lymphoma”
(Phase III)
Keryx Perifosine 218
MB - Sue
“An Open-Label, Phase I/II Study of the Safety and Efficacy of Perifosine
and Bortezomib with or without Dexamethasone for Patients with Relapsed
or Refractory Multiple Myeloma Previously Treated with Bortezomib”
Dartmouth Hitchcock D0410
DP - Ed
“An Observational Study of Avastin (Bevacizumab) in Combination with
Chemotherapy for Treatment of Metastatic or Locally Advanced and
Unresectable Colorectal Cancer, Locally Advanced or Metastatic Non-Small
Cell Lung (Excluding Predominant Squamous Cell Histology), or Locally
Recurrent or Metastatic Breast Cancer”
Note: Effective 1/24/08 the CRC portion of this study is closed to accrual.
“A Phase 2, Multicenter, Open-label, Randomized Trial of AMG 706 or
Bevacizumab in Combination with Paclitaxel and Carboplatin for Advanced
Non-Squamous Non-Small Cell Lung Cancer”
“A National Web-Based Randomized Phase III Study of Erlotinib or
Placebo Following concurrent Docetaxel, Carboplatin and Thoracic
Radiotherapy in Patients with Inoperable Stage III Non-Small Cell Lung
Cancer”
E1505
DP - Ed
“A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without
Bevacizumab for Patients with Completely Resected Stage IB (≥ 4cm) – IIIA NonSmall Cell Lung Cancer (NSCLC)”
Genentech AVF3991n
ARIES
DP - Ed
Amgen 20060136
DP – ED
Lilly H3E-US-B001
DP -Mary
D:\582759935.doc Revised 6FEB2008; 4MAR2008; 1APR2008; 8APR2008; 22APR2008
“Non-Small Cell Lung Cancer: The Impact of Ethnic Origin on Patients being
Treated Second Line with Pemetrexed – an Observational Study”
Page 3
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Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Pulmonary/Lung
NSCLC
Pulmonary/Lung
SCLC
Pulmonary/Lung
SCLC
Skin Cancer
Melanoma
IB-IIIA
OSI-774-302
RADIANT
DP - Kathy
“A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 3
Study of Single-agent Tarceva (erlotinib) Following Complete Tumor
Resection with or without Adjuvant Chemotherapy in Patients with Stage
IB-IIIA Non-Small Cell Lung Carcinoma who have EGF-positive Tumors”
Metastatic
Ascenta AT-101-CS-101
DP - Ed
Phase II only.
“An Open-Label, Multicenter, Phase I/II Study of AT-101 in Combination
with Topotecan in Patients with Relapsed or Refractory Small Cell Lung
Cancer After Prior Platinum Containing First Line Chemotherapy”
Extensive
T3 – T4 or N1
3/25/08 the refractory cohort
suspended for interim analysis.
Genentech AVF3995g
SALUTE
DP - Ed
E1697
DP - Mary
D:\582759935.doc Revised 6FEB2008; 4MAR2008; 1APR2008; 8APR2008; 22APR2008
“A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II
Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell
Lung Cancer”
“A Phase III Randomized Study of Four Weeks High Dose IFN-a2b in
Stage T2b N0, T3a-b, T4a-b N0, and T1-4, N1a, 2a, 3 (microscopic) Melanoma.”
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