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

NCT00267007 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-06-04

Study results available
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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.

Conditions

  • Peripheral Neuropathy, Chemotherapy-induced

Interventions

DRUG

PROCRIT 40,000 IU QW

Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (IV or SC)

DRUG

Placebo

Equivalent volume to PROCRIT (1 mL) administered (QW) for 18 weeks (IV or SC)

Sponsors & Collaborators

  • Ortho Biotech Clinical Affairs, L.L.C.

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00267007 on ClinicalTrials.gov