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
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 1:1 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 Hodgkin's Disease, and the second stratum for children diagnosed with Acute
Lymphocytic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL). The initial dose of study
medication is 600 Units/kg for a maximum dose of 40,000 Units intravenously (IV) weekly, or
placebo, up to 16 weeks. The study medication is adjusted to 900 Units/kg, for a maximum
dose of 60,000 Units IV weekly, if the hemoglobin does not increase by at least 1 g/dL by
Study Week 4/5. Patients were seen and evaluated based on the patient's 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 Units/kg intravenously (IV) of either PROCRIT® or placebo. Initial
dose is 600 Units/kg (maximum dose 40,000 Units IV weekly) up to 16 weeks. If the
hemoglobin does not increase by >= 1 g/dL at Week 4/5, dose is adjusted to 900 Units/kg
(maximum dose 60,000 Units IV weekly).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
Ortho Biotech Products, L.P. Clinical Trial
Study Director
Ortho Biotech Products, L.P.
United States: Institutional Review Board
CR002296
NCT00261677
August 2000
October 2003
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