Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
Recruitment status was Not yet recruiting
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.
Genetic: mutation analysis
Other: laboratory biomarker analysis
|Official Title:||Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients: A Retrospective Study of Tissues From CALGB / SWOG|
- Progression-free survival as measured by RECIST [ Designated as safety issue: No ]
- Relationships between tumor BRAF V600E mutational status, overall survival, and tumor response [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243372
|Principal Investigator:||Najjia N. Mahmoud, MD||Abramson Cancer Center of the University of Pennsylvania|