Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer

Alliance for Clinical Trials in Oncology1,142 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,142

Conditions

Colorectal Cancer

Interventions

mutation analysisGENETIC

laboratory biomarker analysisOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Participation in CALGB-C80405 * Have KRAS WT or KRAS mut tumor * Randomized to treatment with either bevacizumab or cetuximab alone * Patients randomized to the combination therapy are not eligible * Available specimens at the PCO for BRAF mutation detection * Patient consent for use of samples

Outcomes

Primary Outcomes

Progression-free survival as measured by RECIST

Time frame: Up to 36 months

Secondary Outcomes

overall survival

Time frame: Up to 36 months

tumor response as measured by RECIST

Time frame: Up to 36 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.