Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
- Conditions
- Endometrial Cancer
- Registration Number
- NCT00003691
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
- Detailed Description
OBJECTIVES:
* Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma.
* Compare the toxicities of these two regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour.
* Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days.
Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
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 (73)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Memorial Hospital
🇺🇸Worcester, Massachusetts, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Cooper Hospital/University Medical Center
🇺🇸Camden, New Jersey, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Baptist Cancer Institute
🇺🇸Memphis, Tennessee, United States
NCIC-Clinical Trials Group
🇨🇦Kingston, Ontario, Canada
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Cleveland Clinic Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Sooner State
🇺🇸Tulsa, Oklahoma, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Brookview Research, Inc.
🇺🇸Nashville, Tennessee, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Rush-Presbyterian-St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Cancer Center, University of Virginia HSC
🇺🇸Charlottesville, Virginia, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, 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
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, 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
Women's Cancer Center
🇺🇸Palo Alto, California, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
State University of New York Health Sciences Center - Stony Brook
🇺🇸Stony Brook, New York, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Medicine Branch
🇺🇸Bethesda, Maryland, United States
Radiation Oncology Branch
🇺🇸Bethesda, Maryland, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States