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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01209299
First received: September 24, 2010
Last updated: July 1, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention
Melanoma (Skin)
Genetic: DNA methylation analysis
Genetic: gene expression analysis
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Integrated Molecular Signature for the Prediction of Response to Carboplatin/Paclitaxel-Based Chemotherapy in Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation between gene expression and promoter methylation profiles to chemotherapy response [ Designated as safety issue: No ]
  • Predictive model of chemotherapy response [ Designated as safety issue: No ]
  • Association of NER pathway haplotypes with platinum drug resistance and survival [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209299

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Hussein A. Tawbi, MD, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01209299     History of Changes
Other Study ID Numbers: CDR0000683300, ECOG-E2603T1
Study First Received: September 24, 2010
Last Updated: July 1, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IIIC melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sorafenib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014