Studying Biomarkers in Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on E1302 Trial
|ClinicalTrials.gov Identifier: NCT01619618|
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||183 participants|
|Official Title:||Evaluation of Polymorphisms and Mutations in Genes Postulated to Alter the Efficacy of Gefitinib in Samples From E1302|
|Actual Study Start Date :||June 1, 2012|
|Primary Completion Date :||July 1, 2012|
|Study Completion Date :||July 1, 2012|
- 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 ]
- Association between biomarkers and clinical endpoints using logistic regression model and Cox proportional hazards [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619618
|Principal Investigator:||Jill Kolesar, PharmD||University of Wisconsin, Madison|