A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients
- Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit
levels, of interval dosing with epoetin alfa in treating patients with anemia
undergoing chemotherapy for nonhematologic cancer.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Correlate hemoglobin and hematocrit response with patient age (> 65 years vs < 65
years) in patients treated with this drug.
- Determine quality of life of patients treated with this drug.
- Determine the adverse effects of this drug in these patients.
- Determine the change over time of symptom and quality of life variables (e.g., fatigue)
in patients treated with this drug.
OUTLINE: This is a partially randomized, pilot study. Patients are stratified according to
age (< 65 years vs ≥ 65 years). Patients are assigned to 1 of 2 treatment groups based on
participation in the pharmacokinetic (PK) portion of the study.
- Group 1 (PK study, initial therapy): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Five patients receive epoetin alfa subcutaneously (SC) once weekly.
Treatment continues for 24 weeks in the absence of unacceptable toxicity.
- Arm II: Five patients receive epoetin alfa SC once weekly until hematocrit is >
36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance
Patients in both arms also undergo PK sampling periodically during study treatment.
- Group 2 (non-PK study, initial therapy): Fifteen patients receive epoetin alfa SC once
weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients
then proceed to maintenance therapy.
- Maintenance therapy: Patients receive epoetin alfa SC once every other week for up to
24 weeks of total treatment (including both initial therapy and maintenance therapy).
Patients whose blood counts fall below the critical levels are placed on a weekly
dosing schedule. Patients whose blood counts rise too high discontinue study drug until
blood counts are reduced.
Quality of life (including fatigue) is assessed at baseline and then every 4 weeks for 28
After completion of study therapy, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks
Joseph Bubalo, PharmD, BCPS, BCOP
OHSU Knight Cancer Institute
United States: Federal Government
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