Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261677
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-12-02
Brief Title:
A Study to Evaluate the Effect of Weekly PROCRIT Epoetin Alfa or Placebo on Anemia and Quality of Life in Children With Cancer Undergoing Chemotherapy
Sponsor:
Ortho Biotech Products LP
Organization:
Ortho Biotech Products LP
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT Epoetin Alfa on Anemia and Quality of Life in Children With Cancer Undergoing Myelosuppressive Chemotherapy
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 safety and effectiveness of once- weekly dosing of PROCRITÂ a glycoprotein that stimulates red blood cell production versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy and to assess its effect on the quality of life
Detailed Description:
PROCRIT epoetin alfa is an analogue of erythropoetin a hormone secreted by kidneys known to stimulate red blood cell production PROCRIT is approved to be given three times per week to treat anemia in adult cancer patients receiving chemotherapy Once per week dosing in adult cancer patients receiving chemotherapy is investigational and is not approved by the FDA The use of PROCRIT in children with cancer is investigational and is not approved by the FDA Please note Since completion of this study once weekly dosing on PROCRIT in adult cancer patients was approved by FDA in June 2004 and use of PROCRIT in children with cancer was approved by FDA in October 2005 The use of PROCRIT to improve quality of life is investigational and not approved by the FDA This is a randomized double-blind placebo-controlled multicenter study to evaluate the efficacy and safety of once-weekly dosing of PROCRIT or placebo on anemia in children with cancer undergoing myelosuppressive chemotherapy and to assess its effect on the quality of life Patients are randomized into a 11 ratio to receive either PROCRIT or placebo administered intravenously Randomization is stratified by cancer type with one stratum for children diagnosed with a malignant solid tumor or Hodgkins Disease and the second stratum for children diagnosed with Acute Lymphocytic Leukemia ALL or Non-Hodgkins Lymphoma NHL The initial dose of study medication is 600 Unitskg for a maximum dose of 40000 Units intravenously IV weekly or placebo up to 16 weeks The study medication is adjusted to 900 Unitskg for a maximum dose of 60000 Units IV weekly if the hemoglobin does not increase by at least 1 gdL by Study Week 45 Patients were seen and evaluated based on the patients scheduled chemotherapy regimen Patients who received chemotherapy weekly every two weeks or every four weeks 4-week group scheduled study visits occurred every four weeks The study investigated effectiveness of once weekly dosing of PROCRIT on anemia and quality of life in children with cancer undergoing myelosuppressive chemotherapy The primary measure of effectiveness is the change in the patient-reported Pediatric Quality of Life Inventory PedsQL Inventory from baseline to the last assessment Other measures of effectiveness include differences in hemoglobin levels transfusion requirements and quality of life outcomes Safety is assessed by comparing the incidence and severity of adverse experiences in the PROCRIT group versus the placebo group Clinical laboratory tests hematology iron profile and serum chemistry physical examinations and vital sign measurements are also assessed 600 to 900 Unitskg intravenously IV of either PROCRIT or placebo Initial dose is 600 Unitskg maximum dose 40000 Units IV weekly up to 16 weeks If the hemoglobin does not increase by 1 gdL at Week 45 dose is adjusted to 900 Unitskg maximum dose 60000 Units IV weekly
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