Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus
- Conditions
- Sarcoma
- Registration Number
- NCT00003316
- 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.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with recurrent or refractory cancer of the uterus.
- Detailed Description
OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
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 (40)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Radiation Oncology Branch
🇺🇸Bethesda, Maryland, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
NCIC-Clinical Trials Group
🇨🇦Kingston, Ontario, Canada
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States