Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT01243372 |
Recruitment Status :
Completed
First Posted : November 18, 2010
Last Update Posted : July 24, 2020
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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 |
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Colorectal Cancer | Genetic: mutation analysis Other: laboratory biomarker analysis |
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 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 |
Actual Study Start Date : | November 2009 |
Actual Primary Completion Date : | January 2018 |
Actual Study Completion Date : | January 2018 |
Group/Cohort | Intervention/treatment |
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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.
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Genetic: mutation analysis Other: laboratory biomarker analysis |
- Progression-free survival as measured by RECIST [ Time Frame: Up to 36 months ]
- overall survival [ Time Frame: Up to 36 months ]
- tumor response as measured by RECIST [ Time Frame: Up to 36 months ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
DISEASE CHARACTERISTICS:
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Participation in CALGB-C80405
- Have KRAS WT or KRAS mut tumor
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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

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
Principal Investigator: | Najjia N. Mahmoud, MD | Abramson Cancer Center of the University of Pennsylvania |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT01243372 |
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: | July 24, 2020 |
Last Verified: | July 2020 |
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 |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |