tirapazamine plus cisplatin in treating patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

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.

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.

Eligibility 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

Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer