Evaluation of Mitomycin, Doxorubicin and Cisplatin in the Treatment of Recurrent or Advanced Uterine Sarcomas
cisplatin
+ doxorubicin hydrochloride
+ mitomycin C
Neoplasms+1
+ Neoplasms by Histologic Type
+ Neoplasms, Connective and Soft Tissue
Treatment Study
Summary
Study start date: August 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 54 locations
University of Alabama Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama Comprehensive Cancer Center in Google MapsUSC/Norris Comprehensive Cancer Center
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United StatesChao Family Comprehensive Cancer Center
Orange, United States