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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020696
Recruitment Status : Completed
First Posted : February 4, 2004
Last Update Posted : January 10, 2012
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: cisplatin Drug: tirapazamine Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin in Recurrent Platinum Sensitive Ovarian or Primary Peritoneal Cancer
Study Start Date : June 2001
Actual Primary Completion Date : April 2006

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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 tumor


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020696

  Show 54 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Allan Covens, MD Toronto Sunnybrook Regional Cancer Centre

Publications of Results: Identifier: NCT00020696     History of Changes
Other Study ID Numbers: CDR0000068705
First Posted: February 4, 2004    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: March 2008

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents