Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01243372
First received: November 17, 2010
Last updated: July 12, 2016
Last verified: July 2016
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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 |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Alliance for Clinical Trials in Oncology:
Primary Outcome Measures:
- Progression-free survival as measured by RECIST [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- overall survival [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
- tumor response as measured by RECIST [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Tissue
| Estimated Enrollment: | 1142 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | January 2100 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 |
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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 ClinicalTrials.gov identifier: NCT01243372
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional 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 CDR0000688745 |
| Study First Received: | November 17, 2010 |
| Last Updated: | July 12, 2016 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 23, 2016