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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Colorectal Cancer

Treatments: Genetic: mutation analysis; Other: laboratory biomarker analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01243372

CDR0000688745 (Registry Identifier)

CALGB-SWOG-150506-80405-BRAF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,142 participants in 1 patient group

Correlative (BRAF V600E mutation analysis)

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Genetic: mutation analysis