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

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