NCT00640471CompletedPhase 3
A Phase III Randomized Study of Brivanib Alaninate (BMS-582664) in Combination With Cetuximab (Erbitux®) Versus Placebo in Combination With Cetuximab (Erbitux®) in Patients With K-RAS Wild Type Tumors Previously Treated With Combination Chemotherapy for Metastatic Colorectal Carcinoma
NCIC Clinical Trials Group37 sites in 1 country750 target enrollmentStarted: May 12, 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- NCIC Clinical Trials Group
- Enrollment
- 750
- Locations
- 37
- Primary Endpoint
- Overall survival
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
Primary
- To compare the overall survival of patients with previously treated K-Ras wild type metastatic colorectal carcinoma treated with brivanib alaninate in combination with cetuximab versus placebo in combination with cetuximab.
Secondary
- To compare the progression-free survival of these patients.
- To compare the objective response rate and duration of response in these patients.
- To compare the quality of life of these patients.
- To compare the health utilities of these patients.
- To conduct a comparative economic evaluation of these patients.
- To evaluate the safety profile of this regimen in these patients.
- To explore an association between FGF-2, BRAF mutations, amphiregulin (AREG) and epiregulin (EREG) as determined from paraffin embedded tumor specimens and the potential for clinical benefit from the addition of brivanib alaninate or placebo to cetuximab in terms of overall survival, progression-free survival and objective response rate compared to cetuximab alone.
- To explore associations with mRNA and/or protein expression and/or variations in genes associated with epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), angiogenesis, and other related pathways and the potential for clinical benefit from the addition of brivanib alaninate to cetuximab in terms of overall survival, progression-free survival, and objective response rate compared to cetuximab alone.
- To explore an association with changes of Collagen IV in the blood and the potential for clinical benefit from the addition of brivanib alaninate to cetuximab in terms of overall survival, progression-free survival and objective response rate compared to cetuximab alone.
- To establish a comprehensive tumor bank linked to a clinical database for the further study of molecular markers in colorectal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Brivanib
Active Comparator
Intervention: cetuximab (Biological)
Brivanib
Active Comparator
Intervention: brivanib alaninate (Drug)
Placebo
Active Comparator
Intervention: cetuximab (Biological)
Outcomes
Primary Outcomes
Overall survival
Time Frame: 3 years
Secondary Outcomes
- Progression-free survival(3 years)
- Molecular markers(3 years)
- Quality of life (using EORTC QLQ-C30 and Skindex-16 Dermatology Survey)(3 years)
- Safety profile(3 years)
- Health utilities (using HUI3 Health Utilities Index)(3 years)
- Objective response rate(3 years)
- Duration of response(3 years)
- Economic evaluation(3 years)
Investigators
Study Sites (37)
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