NCT00897806

Identifying Genetic Markers That Predict Response to Paclitaxel in Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Feasibility of Measuring Gene Expression Patterns Using Tissue Acquisition of Primary Stage 3 & 4 Epithelial Ovarian Cx or Primary Peritoneal Cx & Gene Expression Array Technology for Predicting Paclitaxel Chemotherapy

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: DNA analysis of tumor tissue from patients with cancer may help doctors predict how patients respond to treatment and plan the best treatment. PURPOSE: This laboratory study is identifying genetic markers that predict response to paclitaxel in patients with newly diagnosed stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.

Detailed description

OBJECTIVES: Primary * Identify genetic markers of paclitaxel chemosensitivity and/or chemoresistance, using gene expression arrays, in patients with newly diagnosed stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with single-agent weekly paclitaxel followed by paclitaxel in combination with carboplatin. * Correlate RNA expression levels with clinical response in patients treated with this regimen. Secondary * Determine the response rate in patients treated with this regimen. * Determine the progression-free survival and overall survival of patients treated with this regimen. * Compare transcriptional profiles of primary tumors vs tissue obtained at second-look surgery in patients treated with this regimen. * Identify differential expression between pre- and post-treatment tissue in patients treated with this regimen. OUTLINE: This is a pilot study. Pre- and post-chemotherapy tumor samples undergo transcriptional profiling using cDNA microarrays to identify gene overexpression. The gene expression profiles of paclitaxel-sensitive tumors are compared with those that are paclitaxel resistant to identify gene markers that are associated with response to paclitaxel. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Conditions

• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
GENETIC	Microarray analysis
OTHER	Laboratory biomarker analysis

Timeline

• Start date: 2002-02-01
• Primary completion: 2006-02-01
• Completion: 2009-02-01
• First posted: 2009-05-12
• Last updated: 2012-07-30

Locations

1 site across 1 country: United States