Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 18 Week Pilot Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) on the Development of Peripheral Neuropathy in Patients Receiving Combination Taxane and Platinum-Based Chemotherapy for Cancer

Peripheral neuropathy is a debilitating disease of the nerves which can be a dose-limiting
toxicity of chemotherapeutic agents. The symptoms of peripheral neuropathy can lead to
considerable patient distress and discomfort, discontinuation of chemotherapy, and
limitations regarding the selection of future chemotherapeutic regimens. Symptoms such as
numbness, weakness, burning pain (especially at night), and loss of reflexes may take months
before they improve and permanent deficits may remain. Epoetin alfa, already used in the
treatment of chemotherapy-induced anemia, has been shown to have neuroprotective effects in
preclinical studies. The purpose of this randomized (patients are assigned different
treatments based on chance), double-blind (neither the patient nor the physician knows
whether drug or placebo is being taken, or at what dosage), placebo-controlled study is to
evaluate the neuroprotective effect of PROCRIT (epoetin alfa) administered once every week
in patients with cancer who develop chemotherapy-induced peripheral neuropathy due to
treatment with combination Taxane and Platinum-Based chemotherapy. Patients will receive
injections subcutaneously or intravenously of either epoetin alfa or placebo once weekly for
up to 18 weeks. Doses may be adjusted in the range of 20,000 to 60,000 Units once a week,
depending on the patient's hemoglobin levels. Safety evaluations will be conducted
throughout the study at specified intervals and will consist of assessment of laboratory
tests (Hemoglobin level, Complete Blood Count (CBC), Blood Chemistries), vital signs,
physical examinations and occurrence and severity of adverse events. In addition, the
occurrence of anti-erythropoietin antibodies at baseline and study completion/early
withdrawal will be evaluated in patients who received PROCRIT (Epoetin alfa) after database
lock and unblinding has occurred. The primary measure of effectiveness is the change at
Week 12 in the National Cancer Institute Common Toxicity Criteria (NCI CTC) neuropathy
score. The study hypothesis is that epoetin alfa will be more effective in the treatment of
chemotherapy-induced peripheral neuropathy than placebo as measured at Week 12 by the
National Cancer Institute Common Toxicity Criteria (NCI CTC) neuropathy score. Patients will
receive injections subcutaneously (SC, under the skin) or intravenously (IV, in a vein) of
either epoetin alfa or placebo once weekly for up to 18 weeks. Doses may be adjusted
depending on the patient's hemoglobin levels to the maximum 60,000 Units once a week. The
minimum dose can be 20,000 Units once a week.