3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III 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 cancer Recurrent or persistent disease At least 1 unidimensionally measurable target lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Outside a previously irradiated field Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease Initial treatment may have included high-dose, consolidation, or extended therapy after surgical or non-surgical assessment Considered platinum resistant or refractory, according to 1 of the following criteria: Treatment-free interval of less than 6 months after platinum-based therapy Disease progression during platinum-based therapy Ineligible for any higher priority GOG protocol Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen) Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens) Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN Creatinine ≤ 1.5 times ULN No serious cardiac disease No prior myocardial infarction No uncontrolled congestive heart failure No pulmonary disease requiring oxygen Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Neuropathy (sensory and motor) ≤ grade 1 No active infections requiring antibiotics No hearing impairment No known G6PD deficiency No other invasive malignancy within the past 5 years except nonmelanoma skin cancer At least 3 weeks since prior biologic or immunologic agents for malignant tumor One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed See Disease Characteristics One prior paclitaxel-containing regimen allowed No prior 3-AP No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens Recovered from prior chemotherapy At least 1 week since prior hormonal therapy for malignant tumor Concurrent hormone replacement therapy allowed No prior radiotherapy to more than 25% of marrow-bearing areas Recovered from prior radiotherapy Recovered from prior surgery No prior cancer therapy that contraindicates receiving study therapy
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (triapine and cisplatin)
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.