RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.
OBJECTIVES: Primary * Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer. * Determine the safety of this drug in these patients. Secondary * Determine the quality of life of patients treated with this drug. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses. * Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL. Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment. After completion of study treatment, patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
89
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Efficacy
Time frame: 7 weeks
Safety
Time frame: 7 weeks
Quality of life
Time frame: 7 weeks
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