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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209299
• Other study ID #: CDR0000683300
• Secondary ID: ECOG-E2603T1
• Status: Completed
• Phase: N/A
• First received: September 24, 2010
• Last updated: May 16, 2017
• Start date: January 19, 2012
• Est. completion date: February 19, 2012

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 19, 2012
• Est. primary completion date: February 19, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Genetic:
• DNA methylation analysis

• gene expression analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between gene expression and promoter methylation profiles to chemotherapy response		1 month