Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Primary
Disease Stage
Protocol
Locally
Advanced or
Metastatic
ACORN AC01B07
PW - Mary
Breast
Breast
Met or locally
advanced
Amgen 20060341
PW – Mary
Title
“A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to
Placebo When Administered in Combination with Chemotherapy for
Patients with Locally Advanced or Metastatic Breast Cancer that has
Progressed During or After Bevacizumab Therapy”
“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”
“An International, Randomized, Double-blind, Placebo-Controlled, Phase 2
Study of AMG 479 with Exemestance or Fulvestrant in Postmenopausal
Women with Hormone Receptor Positive Locally Advanced or Metastatic
Breast Cancer”
Hormone
Receptor Positive
Locally
Advanced or
Met.
Amgen 20070362
PW - Mary
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”
Adjuvant
ECOG N063D
DP – Mary
(suspended as of 06/13/08)
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
Breast
Adjuvant
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)
Breast
Observational
Genentech AVF4349n
Breast
Breast
Breast
Breast
D:\116097462.doc Revised 5JAN09
III
IBCSG 24-02
SOFT
IT - Kathy
“An Observational Study of Treatment Patterns and Safety Outcomes for
Metastatic or Locally Recurrent Breast Cancer (VIRGO)”
“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”
Page 1 of 4
Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
Breast
Digestive
System/GI
Colon or Rectum
Digestive
Systems/GI Colon
Digestive
System/GI
Colon
Digestive
System/GI
Rectal
Digestive
System/GI
Gastric or
Esophagogastric
Junction
Genitourinary/GU
Urothelial Tract or
Bladder
Genitourinary/GU
Prostate
D:\116097462.doc Revised 5JAN09
I-IIIA
IV
III
II
II or III
Locally
Advanced or
Metastatic
NSABP B-42
PW – Mary
CALGB 80405
DP – Ed
Accrual suspended 11/17/08
NCCTG N0147
DP – Ed
“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)
“A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5FU/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”
E5202
DP – Ed
“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”
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”
Amgen 20060317
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with
Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric
Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line
Treatment with Epirubicin, Cisplatin, and Capecitabine (ECX) plus AMG
102
Advanced or
Metastatic
Sanofi-Aventis EFC 6668
NC – Ed
Randomized Study of Larotaxel + Cisplatin vs Gemzar + Cisplatin in 1st
Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder
Cancer”
Metastatic
COUGAR COU-AA-301
NC – Kathy
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of
Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic
Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based
Chemotherapy
Page 2 of 4
Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
GYN
Ovarian, Fallopian
or Primary
Peritoneal CA
GYN
Ovary, Peritoneal,
Fallopian Tube
GYN
Ovarian, Primary
Peritoneal
Advanced
Advanced
Advanced
Multiple Myeloma
Multiple Myeloma
D:\116097462.doc Revised 5JAN09
Genentech AVF4095g
OCEANS
DP – Sue
“A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of
Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinumsensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube
Carcinoma”
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 “
Genentech SHH4489g
“A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled
Trial Evaluating the Efficacy and Safety of GDC-0449 as Maintenance
Therapy in Patients with Ovarian Cancer in a Second or Third Complete
Remission”
Genentech U4391g
NC - Sue
“A Phase III Multicenter, Open-Label Study of Rituximab Faster Infusion
Time in Patients with Previously Untreated Diffuse Large B-Cell or
Follicular Non-Hodgkin’s Lymphoma (RATE Trial)
Advanced
Millennium C05008
MB - Sue
“A Phase I/II Study of VELCADE (Bortezomib), Dexamethasone, and
Revlimid (Lenalidomide) (VDR) versus VELCADE, Dexamethasone,
Cyclophosphamide, and Revlimid (VDR) in Subjects with Previously
Untreated Multiple Myeloma”
Advanced
Novartis CZOL446EUS129
MB - Kathy
GYN
Ovarian
Lymphoma
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
Met. or
Locally
Advanced
“Bone Marker Directed Dosing of ZOMETA® (Zoledronic acid0 for the
Prevention of Skeletal Complications in Patients with Advanced Multiple
Myeloma” – (Z-Mark)
Page 3 of 4
Open Protocols
Hematology Oncology, P.C./Bennett Cancer Center
IV
Genentech AVF3991n
ARIES
DP - Ed
IIIA/B
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 10/20/08 only open for subjects with Stage IV NSCLC.
“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 Non-Small Cell Lung Cancer (NSCLC)”
ImClone CP02-0452
PW - KD
Randomized Phase III Study of Docetaxel or Pemetrexed with or without
Cetuximab in Patients with Recurrent or Progressive Non-Small Cell Lung
Cancer after Platinum-Based Therapy
Observational
Lilly H3E-US-B001
DP -Mary
“Non-Small Cell Lung Cancer: The Impact of Ethnic Origin on Patients
being Treated Second Line with Pemetrexed – an Observational Study”
IB-IIIA
OSI-774-302
RADIANT
DP - Kathy
Multiple Site
NSCLC, Breast
(The CRC portion
closed to accrual
1/24/08)
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
Adjuvant
IB-IIIA
Pulmonary/Lung
NSCLC
Pulmonary/Lung
NSCLC
IIIB, IV
Pulmonary/Lung
NSCLC
Skin Cancer
Melanoma
T3 – T4 or N1
Melanoma
D:\116097462.doc Revised 5JAN09
Stage IV
Metastatic
E1697
DP - Mary
SYNTA 4783-08
SYMMETRY
SD – Ed
“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”
“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.”
“A Randomized, Double-blind, Phase 3 Trial of STA-4783 in Combination
with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy
Naïve Subjects with Stage IV Metastatic Melanoma (SYMMETRY)”
Page 4 of 4