Trial Information

A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Initiated At 40,000 Units Every Week Versus 80,000 Units Every Two Weeks In Anemic Patients With Cancer Receiving Chemotherapy

This is a randomized, open-label, multi-center study to compare end of study hemoglobin
level between Epoetin alfa (PROCRIT) at 40,000 units administered subcutaneously once every
week (qw) and at 80,000 units subcutaneously every two weeks (q2w) in approximately 280
anemic patients with cancer receiving chemotherapy. The study hypothesis is that a dosing
regimen of PROCRIT 80,000 Units q2w subcutaneously (sc) is non-inferior to a dosing regimen
of PROCRIT 40,000 Units qw sc with respect to the change in hemoglobin (Hb) from baseline to
Study Week 13 for patients with chemotherapy associated anemia and this respective dosing
regimen is generally well-tolerated. The patients will receive subcutaneous (under the skin)
injections of Epoetin alfa (PROCRIT) at one of the following dosing regimens: 1- Starting
dose of 40,000 units sc qw (once every week) OR 2- Starting dose of 80,000 units sc q2w
(every two weeks)