Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
- 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.
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|