Biomarkers in Predicting Response to Chemotherapy in Patients With Advanced or Metastatic Melanoma Previously Treated With Carboplatin and Paclitaxel With or Without Sorafenib Tosylate
NCT ID: NCT01209299
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2012-01-19
2012-02-19
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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DNA methylation analysis
gene expression analysis
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of melanoma
* Unresectable locally advanced or stage IV disease
* Received carboplatin and paclitaxel with versus without sorafenib on clinical trial ECOG-E2603
* Archived paraffin-embedded tissue samples
* Responder (complete or partial response, or stable disease) and non-responder (disease progression or unavailable)
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Hussein A. Tawbi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Other Identifiers
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ECOG-E2603T1
Identifier Type: -
Identifier Source: secondary_id
CDR0000683300
Identifier Type: -
Identifier Source: org_study_id
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