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

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01243372

First Posted: November 18, 2010

Last Update Posted: August 8, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

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:

MedlinePlus related topics: Colorectal Cancer

Drug Information available for: Cetuximab

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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

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

Information from the National Library of Medicine

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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

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


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 ( Registry Identifier: NCI Physician Data Query )
First Submitted:	November 17, 2010
First Posted:	November 18, 2010
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

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