RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa
OBJECTIVES:
Primary
- Compare the relative efficacy of four different erythropoietic agent dosing schedules
comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients
with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic
response.
Secondary
- Compare the effect of these regimens on the mean hemoglobin increment measured weekly
from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal
to 10.5 g/dL.
- Compare the time required to achieve hemoglobin levels within the goal range 11.0-12.0
g/dL in patients treated with these regimens.
- Compare the effect of these regimens on the proportion of patients requiring red blood
cell transfusions and on the number of transfusions required.
- Compare the weekly change in hemoglobin in patients treated with these regimens.
- Compare the need for dose reduction in patients treated with these regimens.
- Compare the adverse event profiles of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, unblinded, pilot study. Patients are stratified according to
severity of anemia (mild [hemoglobin ≥ 9.5 g/dL] vs severe [hemoglobin < 9.5 g/dL]),
platinum-containing regimen (yes vs no), and tumor type (nonmyeloid hematologic malignancy
vs solid tumor). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive epoetin alfa subcutaneously (SC) on day 1. Treatment repeats
weekly for up to 15 courses in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm I).
Treatment repeats every 3 weeks for up to 5 courses in the absence of disease
progression or unacceptable toxicity.
- Arm III: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm II).
Treatment repeats every 3 weeks for up to 5 courses in the absence of disease
progression or unacceptable toxicity.
- Arm IV: Patients receive darbepoetin alfa SC on day 1. Treatment repeats every 3 weeks
for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug
dose is administered. Drug dosing is adjusted (e.g., held, reduced, resumed at a lower dose)
as needed to maintain hemoglobin values within the desired ranges.
Quality of life is assessed at baseline and at weeks 4, 7, 10, 13, and 16.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Hematopoietic response (hemoglobin rise of 2 g/dL from baseline OR achievement of hemoglobin within the goal range)
the proportion of patients who exhibit a hematopoietic response (defined as Hb rise >2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period
20 weeks
Charles L. Loprinzi, M.D.
Study Chair
Mayo Clinic
United States: Food and Drug Administration
CDR0000522677
NCT00416624
May 2007
June 2009
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |