Spots Global Cancer Trial Database for FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer

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Trial Identification

Brief Title: FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer

Official Title: A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma

Study ID: NCT00085527

Conditions

Ovarian Cancer

Interventions

depsipeptide

Study Description

Brief Summary: RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory advanced ovarian epithelial cancer.

Detailed Description: OBJECTIVES: Primary * Determine the response rate (complete and partial) in patients with relapsed or refractory advanced ovarian epithelial carcinoma treated with FR901228 (depsipeptide). * Determine the toxicity of this drug in these patients. Secondary * Correlate clinical response with platinum sensitivity in patients treated with this drug. * Correlate clinical response with P-glycoprotein expression or p53 status in patients treated with this drug. OUTLINE: This is multicenter study. Patients are stratified according to response to prior platinum administration (platinum resistant vs platinum sensitive). Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20-37 patients will be accrued for this study within 12 months.