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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00020696
Enrollment
Unknown
Registered
2004-02-04
Start date
2001-06-30
Completion date
Unknown
Last updated
2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Primary Peritoneal Cavity Cancer

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

DRUGcisplatin

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026