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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 17, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

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.

Condition Intervention
Colorectal Cancer
Genetic: mutation analysis
Other: laboratory biomarker analysis

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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival as measured by RECIST [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationships between tumor BRAF V600E mutational status, overall survival, and tumor response [ Designated as safety issue: No ]

Estimated Enrollment: 1142
Study Start Date: November 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01243372

Sponsors and Collaborators
Cancer and Leukemia Group B
Principal Investigator: Najjia N. Mahmoud, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B Identifier: NCT01243372     History of Changes
Other Study ID Numbers: CDR0000688745, CALGB-SWOG-150506-80405-BRAF
Study First Received: November 17, 2010
Last Updated: November 17, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer
stage IIIA colon cancer
stage IIIB colon cancer
stage IIIC colon cancer
stage IVA colon cancer
stage IVB colon cancer
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on May 21, 2015