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Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus

Phase 2
Terminated
Conditions
Sarcoma
Registration Number
NCT00002993
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. Combining more than one drug may kill more tumor cells.

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.

Detailed Description

OBJECTIVES: I. Estimate the antitumor activity of the combination of mitomycin, doxorubicin, and cisplatin (MAP) in patients with recurrent or advanced uterine sarcomas. II. Determine the nature and degree of toxicity of MAP chemotherapy in this cohort of patients.

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
30
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 (54)

Arthur G. James Cancer Hospital - Ohio State University

🇺🇸

Columbus, Ohio, United States

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Pennsylvania Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

Ireland Cancer Center

🇺🇸

Cleveland, Ohio, United States

Medicine Branch

🇺🇸

Bethesda, Maryland, United States

Rush-Presbyterian-St. Luke's Medical Center

🇺🇸

Chicago, Illinois, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University

🇺🇸

Washington, District of Columbia, United States

USC/Norris Comprehensive Cancer Center

🇺🇸

Los Angeles, California, United States

Johns Hopkins Oncology Center

🇺🇸

Baltimore, Maryland, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, United States

Chao Family Comprehensive Cancer Center

🇺🇸

Orange, California, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Radiation Oncology Branch

🇺🇸

Bethesda, Maryland, United States

University of Alabama Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

Albert B. Chandler Medical Center, University of Kentucky

🇺🇸

Lexington, Kentucky, United States

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Indiana University Cancer Center

🇺🇸

Indianapolis, Indiana, United States

University of Texas - MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

University of Minnesota Cancer Center

🇺🇸

Minneapolis, Minnesota, United States

CCOP - Southern Nevada Cancer Research Foundation

🇺🇸

Las Vegas, Nevada, United States

Barrett Cancer Center, The University Hospital

🇺🇸

Cincinnati, Ohio, United States

Barbara Ann Karmanos Cancer Institute

🇺🇸

Detroit, Michigan, United States

CCOP - Ann Arbor Regional

🇺🇸

Ann Arbor, Michigan, United States

University of Massachusetts Memorial Medical Center

🇺🇸

Worcester, Massachusetts, United States

University of Rochester Cancer Center

🇺🇸

Rochester, New York, United States

State University of New York Health Science Center at Brooklyn

🇺🇸

Brooklyn, New York, United States

University of Oklahoma College of Medicine

🇺🇸

Oklahoma City, Oklahoma, United States

Cleveland Clinic Cancer Center

🇺🇸

Cleveland, Ohio, United States

University of Pennsylvania Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Simmons Cancer Center - Dallas

🇺🇸

Dallas, Texas, United States

CCOP - Upstate Carolina

🇺🇸

Spartanburg, South Carolina, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

Tacoma General Hospital

🇺🇸

Tacoma, Washington, United States

University of Washington Medical Center

🇺🇸

Seattle, Washington, United States

MBCCOP - Hawaii

🇺🇸

Honolulu, Hawaii, United States

Lineberger Comprehensive Cancer Center, UNC

🇺🇸

Chapel Hill, North Carolina, United States

Women's Cancer Center

🇺🇸

Palo Alto, California, United States

Cooper Hospital/University Medical Center

🇺🇸

Camden, New Jersey, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

University of Colorado Cancer Center

🇺🇸

Denver, Colorado, United States

Emory University Hospital - Atlanta

🇺🇸

Atlanta, Georgia, United States

State University of New York Health Sciences Center - Stony Brook

🇺🇸

Stony Brook, New York, United States

Abington Memorial Hospital

🇺🇸

Abington, Pennsylvania, United States

Cancer Center of Albany Medical Center

🇺🇸

Albany, New York, United States

Duke Comprehensive Cancer Center

🇺🇸

Durham, North Carolina, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Cancer Center, University of Virginia HSC

🇺🇸

Charlottesville, Virginia, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

North Shore University Hospital

🇺🇸

Manhasset, New York, United States

Fox Chase Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

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