Evaluation of Polymorphisms and Mutations in Genes Postulated to Alter the Efficacy of Gefitinib in Samples From E1302
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Eastern Cooperative Oncology Group
- Enrollment
- 183
- Primary Endpoint
- Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1302 trial.
Detailed Description
OBJECTIVES: * To evaluate the frequency of ATP-binding cassette, sub-family G (WHITE), member 2 (ABCG2), met proto-oncogene (hepatocyte growth factor receptor) (c-MET), and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) polymorphisms or mutations in this study population and the predictiveness of these polymorphisms on survival, time to progression, response rate, and toxicities. OUTLINE: Archived tumor tissue and peripheral blood mononuclear cells are analyzed for the frequency of ABCG2, c-MET, and K-ras polymorphisms or mutations by polymerase chain reaction (PCR). Results are then correlated with patients' clinical outcomes and toxicity.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards
Time Frame: 1 year
The prevalence of c-MET, ABCG2, and K-ras polymorphisms or mutation status summarized by frequency and percentage for all samples
Time Frame: 1 year
Association of c-MET, ABCG2, and K-ras polymorphisms or mutation status with toxicity using Fisher's exact test
Time Frame: 1 year
Association between biomarkers and time to event distribution estimated by by Kaplan-Meier and estimated by log-rank tests
Time Frame: 1 year