Clinical trial NCT00267007: A Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 18 Week Pilot Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) on the Development of Peripheral Neuropathy in Patients Receiving Combination Taxane and Platinum-Based Chemotherapy for Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Peripheral Neuropathy, Chemotherapy-induced
Keywords: Peripheral neuropathy
Chemotherapy-induced
Hemoglobin level
Cancer
Taxane
Platinum-based chemotherapy
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Ortho Biotech Clinical Affairs, L.L.C.
First posted: 2005-12-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.
timeFrame: baseline to Day 128
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Alhambra
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: Fullerton
country: United States
state: California
city: La Verne
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Northridge
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Hollywood
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Joliet
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Bethesda
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: Buffalo
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: