Biomarkers in Predicting Response to Chemotherapy in Patients With Advanced or Metastatic Melanoma Previously Treated With Carboplatin and Paclitaxel With or Without Sorafenib Tosylate
|ClinicalTrials.gov Identifier: NCT01209299|
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : May 17, 2017
RATIONALE: Studying samples of tissue in the laboratory from patients receiving carboplatin and paclitaxel with or without sorafenib tosylate may help doctors learn more about the effects of this treatment on cells. It may also help doctors understand how well patients respond to treatment.
PURPOSE: This research study is studying biomarkers in predicting response to chemotherapy in patients with advanced or metastatic melanoma previously treated with carboplatin and paclitaxel with or without sorafenib tosylate.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Genetic: DNA methylation analysis Genetic: gene expression analysis Other: laboratory biomarker analysis|
- To independently correlate the gene expression and promoter methylation profiles to chemotherapy response in patients with advanced or metastatic melanoma treated with carboplatin and paclitaxel with versus without sorafenib on clinical trial ECOG-E2603.
- To develop a predictive model of chemotherapy response utilizing integrated analysis of gene expression and promoter methylation data.
- To evaluate whether the NER pathway haplotypes are associated with platinum drug resistance and survival.
OUTLINE: This is a multicenter study.
Archived paraffin-embedded tissue samples are analyzed for gene expression and promoter methylation profiles, and genes involved in the NER pathway.
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Integrated Molecular Signature for the Prediction of Response to Carboplatin/Paclitaxel-Based Chemotherapy in Metastatic Melanoma|
|Actual Study Start Date :||January 19, 2012|
|Primary Completion Date :||February 19, 2012|
|Study Completion Date :||February 19, 2012|
- Correlation between gene expression and promoter methylation profiles to chemotherapy response [ Time Frame: 1 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209299
|Principal Investigator:||Hussein A. Tawbi, MD, PhD||University of Pittsburgh|