Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin in Recurrent Platinum Sensitive Ovarian or Primary Peritoneal Cancer

Conditions
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Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: tirapazamine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: tirapazamine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, primary peritoneal cavity cancer