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


N/A
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Correlation between gene expression and promoter methylation profiles to chemotherapy response

Safety Issue:

No

Principal Investigator

Hussein A. Tawbi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

Unspecified

Study ID:

CDR0000683300

NCT ID:

NCT01209299

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IIIC melanoma
  • stage IV melanoma
  • Melanoma

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