Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT01243372
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer.
- Detailed Description
OBJECTIVES:
Primary
* To determine, among patients with advanced CRC, whether the effect of treatment (cetuximab vs bevacizumab) on progression-free survival (PFS) depends on tumor BRAF V600E mutational status.
Secondary
* To study the relationships between tumor BRAF V600E mutational status, OS, and tumor response.
OUTLINE: This is a multicenter study.
Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1142
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival as measured by RECIST Up to 36 months
- Secondary Outcome Measures
Name Time Method overall survival Up to 36 months tumor response as measured by RECIST Up to 36 months