Randomized Phase III Crossover Trial of Chemotherapy (Doxorubicin/Cisplatin/Paclitaxel and G-CSF) Versus Hormonal Therapy (Tamoxifen/Megestrol Acetate) in Patients With Stage III & IV or Recurrent Endometrial Cancer
OBJECTIVES:
- Compare the progression-free survival and response of patients with stage III or IV or
recurrent endometrial cancer treated with doxorubicin, cisplatin, paclitaxel, and
filgrastim (G-CSF) vs tamoxifen and megestrol.
- Compare the survival of patients treated with these regimens.
- Determine if progesterone receptor status provides information on whether patients are
more likely to benefit from chemotherapy.
- Compare the toxicity profiles of these treatment regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, cross-over, multicenter study. Patients are stratified
according to progesterone receptor status (negative vs positive). Patients are randomized to
1 of 2 treatment arms.
- Arm I:Patients receive chemotherapy comprising doxorubicin IV over 15-30 minutes
followed by cisplatin IV over 1 hour on day 1; paclitaxel IV over 3 hours on day 2; and
filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for 10 days.
Chemotherapy repeats every 21 days for up to 7 courses in the absence of disease
progression or unacceptable toxicity.
- At time of disease progression, patients cross-over to hormonal therapy as in arm II.
- Arm II: Patients receive hormonal therapy comprising oral megestrol twice daily on
weeks 1-3 followed by oral tamoxifen twice daily on weeks 4-6. Hormonal therapy repeats
every 6 weeks in the absence of disease progression or unacceptable toxicity.
At time of disease progression, if patients have not previously been enrolled on arm I,
patients cross-over to receive chemotherapy as in arm I.
Quality of life is assessed at baseline, 6 weeks, time of progression, and then after 6
weeks on cross-over therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42
months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Jeffrey D. Bloss, MD
Study Chair
Washington University Siteman Cancer Center
United States: Federal Government
CDR0000068624
NCT00016341
May 2001
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
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 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
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 |
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 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
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 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Community Hospital of Los Gatos | Los Gatos, California 95032 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
Tufts University School of Medicine | Boston, Massachusetts 02111 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Brookview Research, Inc. | Nashville, Tennessee 37203 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Schneider Children's Hospital at North Shore | Manhasset, New York 11030 |
Fletcher Allen Health Care - Medical Center Campus | Burlington, Vermont 05401 |
M.D. Anderson CCOP Research Base | Houston, Texas 77030-4009 |