FR901228 in Treating Patients With Relapsed or Refractory Advanced Ovarian Epithelial Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ovarian epithelial carcinoma Advanced disease Relapsed after OR refractory to 1, and only 1, prior platinum- or taxane-based regimen Refractory disease defined as disease progression during platinum- or taxane-based therapy Relapsed disease defined as platinum or taxane resistant or sensitive Platinum or taxane resistance defined as relapse within 6 months after prior platinum or taxane therapy Platinum or taxane sensitivity defined as relapse > 6 months from the last platinum or taxane treatment Measurable or evaluable disease Measurable disease defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Evaluable disease determined by elevation in CA 125 (≥ 2 times upper limit of normal [ULN]), ascites, or pleural effusion No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status SWOG 0-2 OR Karnofsky 60-100% Life expectancy At least 24 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 WBC ≥ 3,000/mm^3 Hepatic AST and ALT ≤ 2.5 times ULN Bilirubin normal Renal Creatinine normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular QTc < 500 msec LVEF > 40% by MUGA No significant cardiac disease No symptomatic congestive heart failure No unstable or poorly controlled angina pectoris No uncontrolled dysrhythmias No New York Heart Association class III or IV congestive heart failure No myocardial infarction within the past year No prior serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) No left ventricular hypertrophy by EKG Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Potassium ≥ 4.0 mmol/L Magnesium ≥ 2.0 mg/dL No prior allergic reaction attributed to compounds of similar chemical or biological composition to FR901228 (depsipeptide) No concurrent uncontrolled illness No active or ongoing infection No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic agents Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior FR901228 (depsipeptide) No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery Prior surgical resection allowed Other No concurrent drugs known to have HDI activity (e.g., sodium valproate) No concurrent agents that cause QTc prolongation No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent hydrochlorothiazide No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
Arms of the Study
Arm 1
Experimental
depsipeptide
Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.