Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
NCT ID: NCT00020696
Last Updated: 2012-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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cisplatin
tirapazamine
Eligibility Criteria
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Inclusion Criteria
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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Allan Covens, MD
Role: STUDY_CHAIR
Toronto Sunnybrook Regional Cancer Centre
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Radiation Oncology Branch
Bethesda, Maryland, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Brookview Research, Inc.
Nashville, Tennessee, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Tacoma General Hospital
Tacoma, Washington, United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, Australia
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
University of Birmingham
Birmingham, England, United Kingdom
Countries
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References
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Covens A, Blessing J, Bender D, Mannel R, Morgan M; Gynecologic Oncology Group. A phase II evaluation of tirapazamine plus cisplatin in the treatment of recurrent platinum-sensitive ovarian or primary peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Mar;100(3):586-90. doi: 10.1016/j.ygyno.2005.09.032. Epub 2005 Oct 24.
Other Identifiers
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GOG-0146M
Identifier Type: -
Identifier Source: secondary_id
CDR0000068705
Identifier Type: -
Identifier Source: org_study_id
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