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

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ClinicalTrials.gov Identifier: NCT01243372
Recruitment Status : Active, not recruiting
First Posted : November 18, 2010
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Colorectal Cancer Genetic: mutation analysis Other: laboratory biomarker analysis

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 Design
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Study Type : Observational
Estimated Enrollment : 1142 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients: A Retrospective Study of Tissues From CALGB / SWOG
Study Start Date : November 2009
Estimated Primary Completion Date : January 2100

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Correlative (BRAF V600E 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.
 Genetic: mutation analysis Other: laboratory biomarker analysis


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression-free survival as measured by RECIST [ Time Frame: Up to 36 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: Up to 36 months ]
  2. tumor response as measured by RECIST [ Time Frame: Up to 36 months ]

Biospecimen Retention:   Samples With DNA
Tissue

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients previously enrolled on CALGB-C80405 who have KRAS WT or KRAS mut tumor and have been randomized to treatment with either bevacizumab or cetuximab alone in a primary care clinic setting.
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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243372


Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Principal Investigator: Najjia N. Mahmoud, MD Abramson Cancer Center of the University of Pennsylvania
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01243372     History of Changes
Other Study ID Numbers: CALGB-SWOG-150506-80405-BRAF
CALGB-SWOG-150506-80405-BRAF
CDR0000688745 ( Registry Identifier: NCI Physician Data Query )
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Alliance for Clinical Trials in Oncology:
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