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Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus

Phase 2
Terminated
Conditions
Sarcoma
Registration Number
NCT00003156
Lead Sponsor
Gynecologic Oncology Group
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (46)

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Tufts University School of Medicine

🇺🇸

Boston, Massachusetts, United States

Arthur G. James Cancer Hospital - Ohio State University

🇺🇸

Columbus, Ohio, United States

University of Pennsylvania Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Simmons Cancer Center - Dallas

🇺🇸

Dallas, Texas, United States

University of Washington Medical Center

🇺🇸

Seattle, Washington, United States

Barrett Cancer Center, The University Hospital

🇺🇸

Cincinnati, Ohio, United States

Indiana University Cancer Center

🇺🇸

Indianapolis, Indiana, United States

Radiation Oncology Branch

🇺🇸

Bethesda, Maryland, United States

University of Minnesota Cancer Center

🇺🇸

Minneapolis, Minnesota, United States

University of Alabama Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, 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

Rush-Presbyterian-St. Luke's Medical Center

🇺🇸

Chicago, Illinois, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Barbara Ann Karmanos Cancer Institute

🇺🇸

Detroit, Michigan, United States

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, 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

North Shore University Hospital

🇺🇸

Manhasset, New York, United States

State University of New York Health Science Center at Brooklyn

🇺🇸

Brooklyn, 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

Ireland Cancer Center

🇺🇸

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

Abington Memorial Hospital

🇺🇸

Abington, Pennsylvania, United States

University of Oklahoma College of Medicine

🇺🇸

Oklahoma City, Oklahoma, United States

CCOP - Sooner State

🇺🇸

Tulsa, Oklahoma, United States

Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Fox Chase Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

CCOP - Upstate Carolina

🇺🇸

Spartanburg, South Carolina, United States

CCOP - MainLine Health

🇺🇸

Wynnewood, Pennsylvania, United States

CCOP - Baptist Cancer Institute

🇺🇸

Memphis, Tennessee, United States

Brookview Research, Inc.

🇺🇸

Nashville, Tennessee, United States

Cancer Center, University of Virginia HSC

🇺🇸

Charlottesville, Virginia, United States

CCOP - Scott and White Hospital

🇺🇸

Temple, Texas, United States

Fletcher Allen Health Care

🇺🇸

Burlington, Vermont, United States

Tom Baker Cancer Center - Calgary

🇨🇦

Calgary, Alberta, Canada

Tacoma General Hospital

🇺🇸

Tacoma, Washington, United States

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