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

Completed

• Conditions: Colorectal Cancer
• Interventions: Genetic: mutation analysis; Other: laboratory biomarker analysis

• 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1142

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Correlative (BRAF V600E mutation analysis)	mutation analysis	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.
Correlative (BRAF V600E mutation analysis)	laboratory biomarker analysis	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.

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