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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01243372
First received: November 17, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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:

Drug Information available for: Cetuximab
U.S. FDA Resources

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:

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.

  Eligibility

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243372

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov 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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013