Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus
NCT ID: NCT00002993
Last Updated: 2013-07-09
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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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
1997-08-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.
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Detailed Description
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OUTLINE: Patients receive IV doxorubicin, mitomycin, and cisplatin over 3 hours once every 3 weeks, for a minimum of 1 course. Patients who have complete response, partial response, or stable disease will continue for at least 3 courses. If side effects are not severe, patients may remain on the study regimen at the investigator's discretion for a maximum of 6 courses. All patients are followed until death.
PROJECTED ACCRUAL: The first stage of accrual is anticipated to accrue 20 evaluable patients in approximately 12 months. If indicated, a second stage will accrue approximately 10 evaluable patients.
Conditions
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Study Design
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TREATMENT
Interventions
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cisplatin
doxorubicin hydrochloride
mitomycin C
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: No age specified Performance status: Karnofsky 50%-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: Ejection fraction within institutional normal limits Pulmonary: Not specified Other: No active infection No concurrent second malignancy other than nonmelanoma skin cancer Must be disease free of any prior malignancy for at least 5 years and not received any treatments with chemotherapy or radiation therapy for that malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since radiotherapy Recovered from effects of radiotherapy Surgery: Recovered from effects of surgery
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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John H. Edmonson, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Women's Cancer Center
Palo Alto, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, 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
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
MBCCOP - Hawaii
Honolulu, Hawaii, 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
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Medicine Branch
Bethesda, Maryland, United States
Radiation Oncology Branch
Bethesda, Maryland, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 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
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Rochester Cancer Center
Rochester, 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 of Wake Forest University Baptist Medical Center
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 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
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Tacoma General Hospital
Tacoma, Washington, United States
Countries
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References
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Edmonson JH, Blessing JA, Cosin JA, Miller DS, Cohn DE, Rotmensch J. Phase II study of mitomycin, doxorubicin, and cisplatin in the treatment of advanced uterine leiomyosarcoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2002 Jun;85(3):507-10. doi: 10.1006/gyno.2002.6661.
Other Identifiers
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GOG-87I
Identifier Type: -
Identifier Source: secondary_id
CDR0000065540
Identifier Type: -
Identifier Source: org_study_id
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