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Biomarkers in Predicting Response to Chemotherapy in Patients With Advanced or Metastatic Melanoma Previously Treated With Carboplatin and Paclitaxel With or Without Sorafenib Tosylate

Completed
Conditions
Melanoma (Skin)
Registration Number
NCT01209299
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Correlation between gene expression and promoter methylation profiles to chemotherapy response1 month
Secondary Outcome Measures
NameTimeMethod
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