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Sponsored by: |
NCIC Clinical Trials Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00640471 |
RATIONALE: Brivanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving brivanib together with cetuximab is more effective than cetuximab alone in treating patients with metastatic colorectal cancer.
PURPOSE: This randomized phase III trial is studying cetuximab to see how well it works compared with cetuximab given together with brivanib in treating patients with metastatic colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Biological: cetuximab Drug: brivanib alaninate Other: laboratory biomarker analysis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase III Randomized Study of Brivanib Alaninate (BMS-582664) in Combination With Cetuximab (Erbitux®) Versus Placebo in Combination With Cetuximab (Erbitux®) in Patients Previously Treated With Combination Chemotherapy for Metastatic Colorectal Carcinoma |
Estimated Enrollment: | 750 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 2 arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Tumor tissue and blood samples are collected for correlative studies. Samples are analyzed for biomarker levels (Collagen IV, FGF-2, and epiregulin, amphiregulin, and K-ras mutations status) and correlation with response.
After completion of study treatment, patients are followed at 4 weeks and then every 8 weeks thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary colorectal cancer
Must have received a prior thymidylate synthase inhibitor (e.g., fluorouracil, capecitabine, raltitrexed, or tegafur-uracil) for adjuvant and/or metastatic disease
Must meet one of the following criteria:
NOTE: **Documented unsuitability for irinotecan includes known hypersensitivity to irinotecan, abnormal glucuronidation of bilirubin, Gilbert's syndrome, previous pelvic/abdominal irradiation, or elderly with comorbid conditions
Must meet one of the following:
NOTE: **Documented unsuitability for oxaliplatin includes known hypersensitivity to oxaliplatin or other platinum compounds, pre-existing renal impairment, or Grade 2 or greater neurosensory neuropathy
No symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled or significant cardiovascular disease including any of the following:
History of a thromboembolic event in the last 6 months despite being treated with anticoagulation
PRIOR CONCURRENT THERAPY:
Canada, Alberta | |
Cross Cancer Institute at University of Alberta | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Heather-Jane Au 780-432-8762 | |
Tom Baker Cancer Centre - Calgary | Recruiting |
Calgary, Alberta, Canada, T2N 4N2 | |
Contact: Patricia Tang 403-521-3490 | |
Canada, British Columbia | |
BCCA - Fraser Valley Cancer Centre | Recruiting |
Surrey, British Columbia, Canada, V3V 1Z2 | |
Contact: Balvindar S. Johal 604-930-2098 | |
British Columbia Cancer Agency - Centre for the Southern Interior | Recruiting |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
Contact: Sanjay Chandar Rao 250-712-3930 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Hagen Kennecke 604-877-6000 | |
Canada, New Brunswick | |
Doctor Leon Richard Oncology Centre | Recruiting |
Moncton, New Brunswick, Canada, E1C 8X3 | |
Contact: Pierre Whitlock 506-862-4030 | |
Moncton Hospital | Recruiting |
Moncton, New Brunswick, Canada, E1C 6Z8 | |
Contact: Asif Shaikh 506-860-2269 | |
Canada, Newfoundland and Labrador | |
Doctor H. Bliss Murphy Cancer Centre | Recruiting |
St. John's, Newfoundland and Labrador, Canada, AIB 3V6 | |
Contact: Muhammad Zulfiqar 709-777-7802 | |
Canada, Ontario | |
Algoma District Cancer Program at Sault Area Hospital | Recruiting |
Sault Ste. Marie, Ontario, Canada, P6A 2C4 | |
Contact: Bruce D. Keith 705-759-3434 | |
Cancer Care Program at Thunder Bay Regional Health Sciences | Recruiting |
Thunder Bay, Ontario, Canada, P7B 6V4 | |
Contact: Dorie-Anna Dueck 807-684-7204 | |
Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital | Recruiting |
Mississauga, Ontario, Canada, L5M 2N1 | |
Contact: Sudha Rajagopal 905-813-1100 | |
Grand River Regional Cancer Centre at Grand River Hospital | Recruiting |
Kitchener, Ontario, Canada, N2G 1G3 | |
Contact: Gregory J. Knight 519-749-4378 | |
Northeastern Ontario Regional Cancer Centre | Recruiting |
Sudbury, Ontario, Canada, P3E 5J1 | |
Contact: Jonathan Noble 705-522-6237 | |
Ottawa Hospital Regional Cancer Centre - General Campus | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Derek Jonker 613-737-7700 | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Lillian Siu 416-946-2911 | |
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa | Recruiting |
Oshawa, Ontario, Canada, L1G 2B9 | |
Contact: Rafal Wierzbicki 905-576-8711 | |
St. Catharines General Hospital at Niagara Health System | Recruiting |
St. Catharines, Ontario, Canada, L2R 7C6 | |
Contact: Brian Findlay 905-684-7271 | |
Southlake Regional Health Centre | Recruiting |
Newmarket, Ontario, Canada, L3Y 2P9 | |
Contact: Janet A. MacKinnon 905-895-4521 | |
Royal Victoria Hospital of Barrie | Recruiting |
Barrie, Ontario, Canada, L4M 6M2 | |
Contact: Robert El-Maraghi 705-728-9090 | |
Toronto East General Hospital | Recruiting |
Toronto, Ontario, Canada, M4C 3E7 | |
Contact: Richard H-F Shao 416-469-6580 | |
Canada, Quebec | |
Centre Hospitalier Universitaire de Quebec | Recruiting |
Quebec City, Quebec, Canada, G1R 2J6 | |
Contact: Felix Couture 418-691-5225 | |
Hopital du Saint-Sacrement - Quebec | Recruiting |
Quebec City, Quebec, Canada, G1S 4L8 | |
Contact: Catherine Doyle 418-649-5726 | |
Hopital Notre-Dame du CHUM | Recruiting |
Montreal, Quebec, Canada, H2L 4M1 | |
Contact: Danielle Charpentier 514-890-8200 | |
Canada, Saskatchewan | |
Allan Blair Cancer Centre at Pasqua Hospital | Recruiting |
Regina, Saskatchewan, Canada, S4T 7T1 | |
Contact: Muhammad Salim 306-766-2691 | |
Saskatoon Cancer Centre at the University of Saskatchewan | Recruiting |
Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
Contact: Kamal Haider 306-655-2710 |
Study Chair: | Lillian L. Siu, MD, FRCPC | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000590316, CAN-NCIC-CO20, CAN-NCIC-CA182009 |
Study First Received: | March 20, 2008 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00640471 History of Changes |
Health Authority: | Unspecified |
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases |
Recurrence Intestinal Neoplasms Carcinoma Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms |
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Cetuximab Intestinal Diseases Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |