Trial Information

An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Every Three Week Regimen

Epoetin alfa administered three times weekly (150 U/kg) or once weekly (40,000 U) results in
a response rate (defined as >= 2 g/dL Hb increase or Hb >= 12 g/dL) of approximately 65% of
anemic chemotherapy patients and produces a mean hemoglobin (Hg) rise of 1.8 g/dL. Higher
weekly dosing of epoetin alfa may result in a higher response rate and a more timely mean
hemoglobin rise while remaining safe. Additionally, limited data are available to show
whether epoetin alfa maintenance therapy can be administered less frequently than weekly and
still maintain hemoglobin levels. This is an open label, multicenter, non-randomized study
to determine the safety and effectiveness of epoetin alfa given to cancer patients receiving
chemotherapy every three weeks.

Patients will receive injections of PROCRIT (Epoetin alfa) 60,000 Units (U) once weekly
(QW) under the skin for up to 12 weeks (Initiation Phase) to achieve a hemoglobin (Hg) level
of 12 g/dL until next full chemotherapy cycle. At that time they will begin the Maintenance
Phase and will receive up to 4 injections of Epoetin alfa 80,000 U every 3 weeks (Q3W) under
the skin for up to an additional 12 weeks. Doses will be held and adjusted downward if
hemoglobin level rises to >13 g/dL or if a very rapid hemoglobin response occurs (e.g., an
increase of more than 1.3 g/dL in a 2-week period).

Safety evaluations include clinical laboratory tests (hemoglobin and hematocrit), vital sign
measurements (blood pressure), and adverse events. In addition, the antibodies that have
developed against erythropoietin will be evaluated in patients who receive multiple doses of
PROCRIT (Epoetin alfa). Patients will receive injections of Epoetin alfa 60,000 Units (U)
once weekly (QW) under the skin for up to 12 weeks (Initiation Phase) to achieve a
hemoglobin (Hg) level of 12 g/dL until next full chemotherapy cycle. At that time they will
begin the Maintenance Phase and will receive up to 4 injections of Epoetin alfa 80,000 U
every 3 weeks (Q3W) under the skin for up to an additional 12 weeks.