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A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia. PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
OBJECTIVES: * 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 patients. * 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Start Date
June 1, 2003
Primary Completion Date
May 1, 2006
Completion Date
May 1, 2006
Last Updated
July 18, 2016
365
ACTUAL participants
epoetin alfa
BIOLOGICAL
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT06337318
NCT07388563
Data Source & Attribution
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