Ovarian Cancer Clinical Trial
Official title:
A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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