Overview

A Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy

Status:
Terminated
Trial end date:
2008-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the neuroprotective effect of PROCRIT (epoetin alfa, a glycoprotein that stimulates red blood cell production) versus placebo in patients with cancer who develop chemotherapy-induced peripheral neuropathy due to combination Taxane and Platinum-Based treatment.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Treatments:
Epoetin Alfa
Neuroprotective Agents
Criteria
Inclusion Criteria:

- Patients with a diagnosis of cancer , and no history of peripheral neuropathy

- Have had the appropriate surgery for carcinoma and are no more than 12 weeks
post-operatively at study entry

- Have not received chemotherapy (chemotherapy naïve patients) and are scheduled to
receive at least 4 cycles of combination taxane and platinum-based chemotherapy

- Have a hemoglobin value of >= 10 and < 12 g/dL

- have a life expectancy of at least 6 months

Exclusion Criteria:

- Patients who have had prior treatment with PROCRIT (epoetin alfa) or similar drugs
(erythropoietic agents) within the last 2 months

- Have used experimental treatments within the last year that are reported or
hypothesized to have neuroprotective potential, including amifostine, cyanocobalamin
(vitamin B12), alpha-tocopherol (Vitamin E), glutamine, and gabapentin

- have anemia due to factors other than cancer/chemotherapy, or have ongoing neuropathy
due to any cause

- Received a transfusion of platelets or packed red blood cells within 28 days prior to
the first dose of study medication

- Have a history of pulmonary emboli, deep vein thrombosis, ischemic stroke or any other
history of arterial or venous thrombotic events