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
Condition: Anemia; Hodgkin Disease; Leukemia; Lymphoma, Non-hodgkin
MeSH terms: Hodgkin Disease; Lymphoma, Non-Hodgkin; Anemia
Study type: Interventional
Phase: Phase 3

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
      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).
    

Intervention name(s): epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Anemia; cancer; solid tumor; Hodgkin's Disease; Acute Lymphocytic Leukemia (ALL); Non-Hodgkin's Lymphoma (NHL); Quality of Life; hemoglobin; Epoetin alfa