Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267007
Status:
TERMINATED
Last Update Posted:
2014-06-04
First Post:
2005-12-16
Brief Title:
A Study to Investigate the Neuroprotective Effect of PROCRIT Epoetin Alfa Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 20000 to 60000 Units once a week depending on the patients 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 completionearly 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 patients hemoglobin levels to the maximum 60000 Units once a week The minimum dose can be 20000 Units once a week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None