Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Cavity Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer Recurrent or persistent disease Disease progression during OR persistent disease after completion of 1 prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or other organoplatinum compound) for primary disease Initial treatment may have included high-dose, consolidation, noncytotoxic agents, or extended therapy administered after surgical or non-surgical assessment Treatment-free interval after completion of platinum-based chemotherapy must have been < 12 months Measurable disease, defined as ≥ 1 unidimensionally measurable target* lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) No known brain metastases Performance status - GOG 0-1 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Able to take oral medication No bowel obstruction No persistent vomiting No parenteral feeding Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment No neuropathy (sensory and motor) > grade 1 No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No active infection requiring antibiotics No psychiatric illness or social situation that would preclude study compliance No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat No other uncontrolled illness At least 4 weeks since prior immunotherapy for the malignancy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for the malignancy and recovered No more than 2 prior cytotoxic chemotherapy regimens for recurrent or persistent disease No prior non-cytotoxic chemotherapy for recurrent or persistent disease, unless therapy was part of the primary treatment regimen No prior vorinostat At least 1 week since prior hormonal therapy for the malignancy Concurrent hormone replacement therapy allowed At least 4 weeks since prior radiotherapy for the malignancy and recovered No prior radiotherapy to > 25% of bone marrow At least 4 weeks since prior surgery for the malignancy and recovered At least 4 weeks since other prior therapy for the malignancy At least 30 days since prior and no concurrent valproic acid Concurrent oral anticoagulants (i.e., warfarin) allowed provided there is increased vigilance with respect to monitoring PT/INR for the first 2 courses of study therapy or if there are any signs of bleeding No prior anticancer therapy that would preclude study participation No concurrent combination anti-retroviral therapy for HIV-positive patients No other concurrent investigational agents
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (vorinostat)
Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.