Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed primary ovarian epithelial or peritoneal cavity cancer

  • Histologic confirmation of recurrent disease not required
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, computed tomography [CT] scan, or magnetic resonance imaging [MRI]) OR ≥ 10 mm by spiral CT scan

• Achieved a complete response after initial prior platinum-containing (cisplatin or carboplatin) chemotherapy regimen (e.g., conventional-dose therapy, high-dose therapy, consolidation therapy, or extended therapy after surgical or nonsurgical assessment)

  • Patients who have not received paclitaxel or docetaxel as initial therapy may receive a second regimen containing these drugs
  • No prior chemotherapy for persistent or recurrent disease, including re-treatment with the original regimen
• Platinum-sensitive disease, defined as having a treatment-free interval with no evidence of progressive disease for > 6 but < 12 months after completion of a platinum-based regimen
• No known brain metastases
• Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
• Performance status - Karnofsky 60-100%
• More than 6 months
• White blood cells (WBC) ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin normal
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• Creatinine clearance ≥ 60 mL/min
• No New York Heart Association class III or IV congestive heart failure
• No myocardial infarction within the past year
• No uncontrolled dysrhythmias
• No poorly controlled angina
• No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation, ≥ 3 beats in a row)
• QTc interval < 500 msec
• No other significant cardiac disease
• Potassium normal
• Magnesium normal
• No uncontrolled electrolyte abnormality (hypokalemia and hypomagnesemia)
• No ongoing or active infection requiring antibiotics
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to study drug
• No neuropathy ≥ grade 2
• No other uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior monoclonal antibodies, cytokines, or signal transduction inhibitors for recurrent disease
• No concurrent biologic therapy
• See Disease Characteristics
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for the primary malignancy
• No prior FR901228 (depsipeptide)
• No other concurrent chemotherapy
• More than 4 weeks since prior hormonal therapy for the primary malignancy
• Concurrent estrogen replacement therapy allowed
• More than 4 weeks since prior radiotherapy
• No prior radiotherapy to > 25% of bone marrow
• No concurrent radiotherapy
• Recovered from all prior therapy
• More than 4 weeks since prior noncytotoxic therapy for the primary malignancy
• No other prior noncytotoxic therapy for recurrent disease
• No concurrent combination anti-retroviral therapy for HIV-positive patients
• No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g., valproic acid)
• No concurrent agents that cause QTc prolongation
• No other concurrent investigational agents
• No other concurrent anticancer agents