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

Phase 2
Open (Enrolling)

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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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John H. Edmonson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

Related Keywords:

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



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