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

NCT01209299 | Completed

• 2 other identifiers: CDR0000683300ECOG-E2603T1
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IIIC melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Correlation between gene expression and promoter methylation profiles to chemotherapy response

  1 month

Interventions

DNA methylation analysis GENETIC

gene expression analysis GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples from patients enrolled on E2603 from whom samples were submitted for research

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Melanoma

Interventions

DNA Methylation; Gene Expression Profiling

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; Genetic Techniques; Investigative Techniques

Study Officials

• Hussein A. Tawbi, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: January 19, 2012
• Primary Completion: February 19, 2012
• Study Completion: February 19, 2012
• Last Updated: May 17, 2017

Record last verified: 2017-05