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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

Phase 2
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


- Determine the antitumor activity of tirapazamine and cisplatin in patients with
persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal

- 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.

Inclusion Criteria


- 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



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- 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


- Creatinine no greater than 1.5 times ULN


- No prior or concurrent myocardial infarction or ischemic heart disease


- 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


Biologic therapy:

- At least 3 weeks since prior biologic or immunological agents directed at malignant


- 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


- 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


- See Disease Characteristics

- Recovered from prior surgery


- No prior cancer treatment that would preclude study

- At least 3 weeks since other prior therapy directed at malignant tumor

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Allan Covens, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Odette Cancer Centre at Sunnybrook


United States: Federal Government

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



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