Ovarian Cancer, Primary Peritoneal Cavity Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining tirapazamine with cisplatin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.
Detailed description
OBJECTIVES: * Determine the antitumor activity of tirapazamine and cisplatin in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma. * Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive tirapazamine IV over 2 hours followed 1 hour later by cisplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed persistent or recurrent ovarian epithelial or primary peritoneal carcinoma * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Platinum-sensitive disease * Treatment-free interval of more than 6 months without clinical evidence of progressive disease after a response to a platinum compound * One prior chemotherapy regimen containing cisplatin or another platinum compound for primary disease required * Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * Patients not previously treated with paclitaxel may receive a second regimen containing paclitaxel * No additional cytotoxic chemotherapy (including retreatment with initial regimens) for recurrent or persistent disease * Ineligible for a higher priority GOG protocol (any active GOG phase III protocol for the same patient population) * Treatment-free interval of more than 12 months if non-platinum-based GOG-0146 series protocol is active concurrently with this protocol PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * 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 Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No prior or concurrent myocardial infarction or ischemic heart disease Other: * No active infection requiring antibiotics * No sensory or motor neuropathy greater than grade 1 * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic or immunological agents directed at malignant tumor Chemotherapy: * See Disease Characteristics * Recovered from prior chemotherapy * No prior tirapazamine Endocrine therapy: * At least 1 week since prior hormonal therapy directed at malignant tumor * Concurrent hormone replacement therapy allowed Radiotherapy: * Recovered from prior radiotherapy * No prior radiotherapy to site(s) of measurable disease used on this study * No prior radiotherapy to more than 25% of bone marrow Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * No prior cancer treatment that would preclude study * At least 3 weeks since other prior therapy directed at malignant tumor
Countries
Australia, Canada, United Kingdom, United States