A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both.
Quality of life is also affected, in part because of the fatigue associated with anemia.
Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level
may improve quality of life and help patients live longer. This study is a 12-week,
double-blind, placebo-controlled multicenter study to compare the ability of epoetin alfa
and placebo in reducing or preventing anemia and transfusions, and to investigate
quality-of-life benefits associated with the use of epoetin alfa in patients receiving
chemotherapy for selected cancers. During the double-blind period there will be two groups
of patients: one group receiving epoetin injections under the skin 3 times per week
(starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per
kilogram) and other group receiving injections under the skin of a placebo of matching
appearance and volume. If hemoglobin rises above 140 grams per liter (women) or 150 grams
per liter (men), the dose will be adjusted to keep hemoglobin within a target range. A
12-week open-label extension of the study will be available to all patients completing the
12-week comparison period. The primary measure of effectiveness is determined by the
proportion of patients with no transfusions after the first month. Additional measures of
effectiveness include: the proportion of responders, the change of hemoglobin unrelated to
transfusion, cumulative transfusion rate and proportion of patients transfused during the
double-blind phase (excluding the first month), as well as the mean change over the study
period in scores for energy, activity and overall quality of life. The results will be
analyzed separately for non-platinum-containing chemotherapy and for different tumor types.
Safety evaluations include assessments of the incidence and severity of adverse events,
clinical laboratory tests, vital sign measurements, and physical examinations. The
hypothesis of the study is that epoetin alfa is superior to placebo in improving anemia,
reducing the number of transfusions, and improving quality of life. Epoetin alfa 150 units
(U) per kilogram (kg) or placebo, injected under the skin 3 times weekly for 4 weeks; then
either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the
remaining 8 weeks. Open-label (12 weeks): dose to maintain target hemoglobin range.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Proportion of patients without transfusion after first month.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Institutional Review Board