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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Primary Peritoneal Cavity Cancer; Ovarian Cancer

Treatments: Drug: cisplatin; Drug: tirapazamine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00020696

GOG-0146M

CDR0000068705

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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