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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)

University of Alabama Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

USC/Norris Comprehensive Cancer Center

🇺🇸

Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center

🇺🇸

Orange, California, United States

Women's Cancer Center

🇺🇸

Palo Alto, California, United States

University of Colorado Cancer Center

🇺🇸

Denver, Colorado, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University

🇺🇸

Washington, District of Columbia, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Emory University Hospital - Atlanta

🇺🇸

Atlanta, Georgia, United States

Scroll for more (44 remaining)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

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