Evaluation of Mitomycin, Doxorubicin and Cisplatin in the Treatment of Recurrent or Advanced Uterine Sarcomas
Phase 2
N/A
N/A
N/A
N/A
Open (Enrolling)
Female
Sarcoma
Female
Sarcoma
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 |
