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

NCT ID: NCT00267007

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-08-31

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 develop chemotherapy-induced peripheral neuropathy due to combination Taxane and Platinum-Based treatment.

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 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.

Conditions

Peripheral Neuropathy, Chemotherapy-induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

001

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

Group Type: EXPERIMENTAL

PROCRIT 40,000 IU QW

Intervention Type: DRUG

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

002

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

PROCRIT 40,000 IU QW

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech Clinical Affairs, L.L.C.

INDUSTRY

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Mobile, Alabama, United States

Little Rock, Arkansas, United States

Alhambra, California, United States

Bakersfield, California, United States

Fullerton, California, United States

La Verne, California, United States

Long Beach, California, United States

Northridge, California, United States

Oxnard, California, United States

Santa Maria, California, United States

New Haven, Connecticut, United States

Hollywood, Florida, United States

Augusta, Georgia, United States

Joliet, Illinois, United States

Indianapolis, Indiana, United States

Lexington, Kentucky, United States

Bethesda, Maryland, United States

Detroit, Michigan, United States

Southfield, Michigan, United States

Las Vegas, Nevada, United States

Lebanon, New Hampshire, United States

Buffalo, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Winston-Salem, North Carolina, United States

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Chattanooga, Tennessee, United States

Countries

United States

Other Identifiers

CR003247

Identifier Type: -

Identifier Source: org_study_id