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Brief Title: Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus
Official Title: Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus
Study ID: NCT00003156
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with recurrent or refractory cancer of the uterus.
Detailed Description: OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the nature and degree of toxic effects of topotecan in these patients. OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease continue treatment for at least three courses. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then periodically thereafter until death. PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2 years.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama 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
Walter Reed Army Medical Center, Washington, 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
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Radiation Oncology Branch, Bethesda, Maryland, United States
Tufts University School of Medicine, Boston, Massachusetts, 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
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, 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
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 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
CCOP - Sooner State, Tulsa, 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
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
CCOP - Baptist Cancer Institute, Memphis, Tennessee, United States
Brookview Research, Inc., Nashville, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Fletcher Allen Health Care, Burlington, Vermont, 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
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada
Name: David S. Miller, MD
Affiliation: Simmons Cancer Center
Role: STUDY_CHAIR