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

NCT01243372 | Completed

• 2 other identifiers: CALGB-SWOG-150506-80405-BRAFCDR0000688745
• Study Type: observational
• Target: 1,142
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival as measured by RECIST

  Up to 36 months

Secondary Outcomes (2)

• overall survival

  Up to 36 months

• tumor response as measured by RECIST

  Up to 36 months

Study Arms (1)

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

Interventions

mutation analysis GENETIC

Correlative (BRAF V600E mutation analysis)

laboratory biomarker analysis OTHER

Correlative (BRAF V600E mutation analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Najjia N. Mahmoud, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 24, 2020

Record last verified: 2020-07