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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Tirapazamine

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