Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
- Conditions
- Sarcoma
- Registration Number
- NCT00033644
- 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. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.
- Detailed Description
OBJECTIVES:
* Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
* Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5 minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3 before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients achieving complete or partial response receive a maximum of 6 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Tuft-New England Medical Center
🇺🇸Boston, Massachusetts, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Norwegian Radium Hospital
🇳🇴Oslo, Norway
Cooper University Hospital
🇺🇸Camden, New Jersey, United States