Status:
TERMINATED
A Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Clinical Affairs, L.L.C.
Conditions:
Peripheral Neuropathy, Chemotherapy-induced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 devel...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00267007
Start Date
June 1 2006
End Date
August 1 2008
Last Update
June 4 2014
Active Locations (28)
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1
Mobile, Alabama, United States
2
Little Rock, Arkansas, United States
3
Alhambra, California, United States
4
Bakersfield, California, United States