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
- 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
PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42
Allocation: Randomized, Primary Purpose: Treatment
Jeffrey D. Bloss, MD
Washington University Siteman Cancer Center
United States: Federal Government
|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|