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Completed

NCT Number: NCT01243372

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mutation analysis

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Progression-free survival as measured by RECIST

    Time frame: Up to 36 months

Secondary outcomes

  1. overall survival

    Time frame: Up to 36 months

  2. tumor response as measured by RECIST

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients: A Retrospective Study of Tissues From CALGB / SWOG

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Nov 18, 2010
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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