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

Trial Information

Evaluation of Mitomycin, Doxorubicin and Cisplatin in the Treatment of Recurrent or Advanced Uterine Sarcomas

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent, or recurrent
uterine sarcoma Documented disease progression after local therapy Measurable disease
consisting of abdominal, pelvic, chest, or other masses that can be defined in at least
two dimensions by palpation, x-ray, computed tomography or ultrasound

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

John H. Edmonson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000065540

NCT ID:

NCT00002993

Start Date:

August 1997

Completion Date:

Related Keywords:

Sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
Uterine Neoplasms
Sarcoma

Name	Location
Memorial Sloan-Kettering Cancer Center	New York, New York 10021
University of Texas - MD Anderson Cancer Center	Houston, Texas 77030-4009
University of Alabama Comprehensive Cancer Center	Birmingham, Alabama 35294
Jonsson Comprehensive Cancer Center, UCLA	Los Angeles, California 90095-1781
USC/Norris Comprehensive Cancer Center	Los Angeles, California 90033-0800
Chao Family Comprehensive Cancer Center	Orange, California 92868
University of Colorado Cancer Center	Denver, Colorado 80262
Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington, District of Columbia 20007
Walter Reed Army Medical Center	Washington, District of Columbia 20307-5000
H. Lee Moffitt Cancer Center and Research Institute	Tampa, Florida 33612
Emory University Hospital - Atlanta	Atlanta, Georgia 30322
MBCCOP - Hawaii	Honolulu, Hawaii 96813
Rush-Presbyterian-St. Luke's Medical Center	Chicago, Illinois 60612
University of Chicago Cancer Research Center	Chicago, Illinois 60637
Indiana University Cancer Center	Indianapolis, Indiana 46202-5265
University of Iowa Hospitals and Clinics	Iowa City, Iowa 52242
Albert B. Chandler Medical Center, University of Kentucky	Lexington, Kentucky 40536-0084
Johns Hopkins Oncology Center	Baltimore, Maryland 21287
University of Massachusetts Memorial Medical Center	Worcester, Massachusetts 01655
CCOP - Ann Arbor Regional	Ann Arbor, Michigan 48106
Barbara Ann Karmanos Cancer Institute	Detroit, Michigan 48201
University of Minnesota Cancer Center	Minneapolis, Minnesota 55455
University of Mississippi Medical Center	Jackson, Mississippi 39216-4505
Washington University School of Medicine	Saint Louis, Missouri 63110
Cooper Hospital/University Medical Center	Camden, New Jersey 08103
Cancer Center of Albany Medical Center	Albany, New York 12208
State University of New York Health Science Center at Brooklyn	Brooklyn, New York 11203
University of Rochester Cancer Center	Rochester, New York 14642
State University of New York Health Sciences Center - Stony Brook	Stony Brook, New York 11790-7775
Lineberger Comprehensive Cancer Center, UNC	Chapel Hill, North Carolina 27599-7295
Duke Comprehensive Cancer Center	Durham, North Carolina 27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem, North Carolina 27157-1082
Barrett Cancer Center, The University Hospital	Cincinnati, Ohio 45219
Cleveland Clinic Cancer Center	Cleveland, Ohio 44195
Ireland Cancer Center	Cleveland, Ohio 44106-5065
Arthur G. James Cancer Hospital - Ohio State University	Columbus, Ohio 43210
University of Oklahoma College of Medicine	Oklahoma City, Oklahoma 73190
Abington Memorial Hospital	Abington, Pennsylvania 19001
Milton S. Hershey Medical Center	Hershey, Pennsylvania 17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia, Pennsylvania 19107
University of Pennsylvania Cancer Center	Philadelphia, Pennsylvania 19104
Fox Chase Cancer Center	Philadelphia, Pennsylvania 19111
Medical University of South Carolina	Charleston, South Carolina 29425-0721
CCOP - Upstate Carolina	Spartanburg, South Carolina 29303
Simmons Cancer Center - Dallas	Dallas, Texas 75235-9154
Cancer Center, University of Virginia HSC	Charlottesville, Virginia 22908
University of Washington Medical Center	Seattle, Washington 98195-6043
Tacoma General Hospital	Tacoma, Washington 98405
Women's Cancer Center	Palo Alto, California 94304
CCOP - Southern Nevada Cancer Research Foundation	Las Vegas, Nevada 89106
Pennsylvania Hospital	Philadelphia, Pennsylvania 19107
North Shore University Hospital	Manhasset, New York 11030
Medicine Branch	Bethesda, Maryland 20892
Radiation Oncology Branch	Bethesda, Maryland 20892

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