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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Response rate of depsipeptide in ovarian cancer
Time frame: 8 weeks
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