Biomarkers in Predicting Response to Chemotherapy in Patients With Advanced or Metastatic Melanoma Previously Treated With Carboplatin and Paclitaxel With or Without Sorafenib Tosylate
Recruitment status was: Not yet recruiting
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.
Genetic: DNA methylation analysis
Genetic: gene expression analysis
Other: laboratory biomarker analysis
|Official Title:||Integrated Molecular Signature for the Prediction of Response to Carboplatin/Paclitaxel-Based Chemotherapy in Metastatic Melanoma|
- Correlation between gene expression and promoter methylation profiles to chemotherapy response [ Designated as safety issue: No ]
- Predictive model of chemotherapy response [ Designated as safety issue: No ]
- Association of NER pathway haplotypes with platinum drug resistance and survival [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209299
|Principal Investigator:||Hussein A. Tawbi, MD, PhD||University of Pittsburgh|