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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Peripheral Neuropathy, Chemotherapy-induced

In brief

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.

Key facts

Study ID

NCT00267007

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

32

Starts

2006-06-01

Expected to finish

2008-08-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Alhambra, California, United States
• Study site — Bakersfield, California, United States
• Study site — Fullerton, California, United States
• Study site — La Verne, California, United States
• Study site — Long Beach, California, United States
• Study site — Northridge, California, United States
• Study site — Oxnard, California, United States
• Study site — Santa Maria, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Hollywood, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Joliet, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Bethesda, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Buffalo, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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