Ovarian Cancer Clinical Trial
Official title:
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
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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