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

Integrated Molecular Signature for the Prediction of Response to Carboplatin/Paclitaxel-Based Chemotherapy in Metastatic Melanoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01209299

Enrollment

Registered

2010-09-27

Start date

2012-01-19

Completion date

2012-02-19

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma, stage IIIC melanoma, stage IV melanoma

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.

Interventions

GENETICDNA methylation analysis

GENETICgene expression analysis

OTHERlaboratory biomarker analysis

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * 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

Design outcomes

Primary

Measure	Time frame
Correlation between gene expression and promoter methylation profiles to chemotherapy response	1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026