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Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer Clinical research trials and Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer. Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer clinical trial. Human subjects often get the best healthcare possible for their Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer  Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
For Condition: peritoneal cavity cancer,recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: 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 tirapazamine plus cisplatin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.
Details: OBJECTIVES: I. Determine the antitumor activity of tirapazamine and cisplatin in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma. II. Determine the nature and degree of toxicity of this regimen in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --Patient Characteristics-- - Age: Not specified - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - 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 - 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 nonmelanomatous skin cancer; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AllanCovens, Study Chair, Gynecologic Oncology Group
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, 1450
Australia
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Radiation Oncology Branch
Bethesda, Maryland, 20892
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Additional Information:
Study ID Numbers: CDR0000068705; GOG-0146M
Study Start Date: June 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020696
Other Peritoneal Cavity Cancer Studies:
1. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer
2. Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer
4. Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
5. Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
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