A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)
Epoetin alfa is an analogue (has the identical amino acid sequence) of erythropoetin, a
hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin
alfa has been known to be effective in treatment of anemia associated with cancer
chemotherapy, there are no specific formal guidelines on the use of epoetin alfa for the
treatment of anemia in cancer patients not receiving chemotherapy or radiation therapy.
Several prospective clinical trials investigating the efficacy of epoetin alfa in
cancer-associated anemia included groups of patients not receiving chemotherapy where it was
demonstrated that the use of epoetin alfa in this population was safe and effective in
increasing hemoglobin (Hb) levels and reducing transfusion requirements. The optimal dosing
regimen of epoetin alfa in cancer patients not receiving chemotherapy or radiation therapy
This 17-week study is a prospective, randomized, open-label, multi-center study to assess
the safety and effectiveness of epoetin alfa in anemic patients with cancer not receiving
chemotherapy or radiation therapy. Eligible patients with hemoglobin level <= 11 g/dL will
receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks
for 13 weeks. The study hypothesis are that there are no long-term safety concerns of
epoetin alfa administered at these two dosing regimens and that both dosing regimens are
equally effective in this patient population. Eligible patients with hemoglobin levels <= 11
g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once
every 4 weeks for 13 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration