A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
- Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion
requirements in anemic patients with nonmyeloid cancer.
- Compare the effects of these regimens on increasing hemoglobin levels in these
- Compare the effects of these regimens on overall quality of life (QOL) and
anemia-specific components of QOL in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or
carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL]
vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of
neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder
[including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms).
All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks.
Patients are then randomized to 1 of 2 treatment arms.
- Arm I: Patients receive EPO SC once weekly for 18 weeks.
- Arm II: Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of
life is assessed at randomization at then monthly during study treatment.
Patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Supportive Care
David P. Steensma, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Duluth||Duluth, Minnesota 55805|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Mayo Clinic||Jacksonville, Florida 32224|
|Altru Cancer Center||Grand Forks, North Dakota 58206|
|CCOP - Mayo Clinic Scottsdale Oncology Program||Scottsdale, Arizona 85259|