A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Gini F. Fleming, MD
Study Chair
University of Chicago
United States: Federal Government
CDR0000066794
NCT00003691
December 1998
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
University of Rochester Cancer Center | Rochester, New York 14642 |
State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Cancer Center, University of Virginia HSC | Charlottesville, Virginia 22908 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
Women's Cancer Center | Palo Alto, California 94304 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
CCOP - Baptist Cancer Institute | Memphis, Tennessee 38117 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Tufts University School of Medicine | Boston, Massachusetts 02111 |
Brookview Research, Inc. | Nashville, Tennessee 37203 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
CCOP - Greenville | Greenville, South Carolina 29615 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
North Shore University Hospital | Manhasset, New York 11030 |
Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
CCOP - Sooner State | Tulsa, Oklahoma 74136 |
Medicine Branch | Bethesda, Maryland 20892 |
Radiation Oncology Branch | Bethesda, Maryland 20892 |
Memorial Hospital | Worcester, Massachusetts 01605 |