Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal 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 carcinoma Recurrent or persistent disease At least 1 unidimensionally measurable target lesion* defined as: At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment Patients who have not received prior paclitaxel may receive a second regimen containing paclitaxel Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population) Platinum-sensitive disease Platinum-free interval** of more than 6 months, but less than 12 months duration, with no clinical evidence of progressive disease after response to platinum Performance status - GOG 0-2 for patients who received 1 prior therapy regimen Performance status - GOG 0-1 for patients who received 2 prior therapy regimens Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine normal Creatinine clearance at least 60 mL/min No prior congestive heart failure requiring medication No uncontrolled hypertension within the past 6 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other invasive malignancies within the past 5 years except nonmelanoma skin cancer No history of retinopathy and/or macular degeneration No neuropathy (sensory and motor) greater than grade 1 No active infection requiring antibiotics No other illness or condition that would preclude study entry No prior bone marrow or stem cell transplantation At least 3 weeks since prior biologic therapy or immunotherapy for malignant tumor One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) allowed See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior irofulven No additional prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens At least 1 week since prior hormonal therapy for malignant tumor Concurrent hormone replacement therapy allowed See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of marrow-bearing areas Recovered from recent prior surgery At least 3 weeks since any other prior therapy for malignant tumor No prior anticancer treatment that would preclude study therapy One prior noncytotoxic cytostatic regimen for recurrent or persistent disease allowed
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (irofulven)
Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.