Lymphoma Clinical Trial
Official title:
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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