The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy
Condition: Anemia; Multiple Myeloma; Lymphoma; Breast Cancer; Ovarian Cancer; Carcinoma, Small Cell Lung; Esophagus Cancer; Prostate Cancer; Neoplasm
MeSH terms: Multiple Myeloma; Esophageal Neoplasms; Carcinoma, Small Cell; Small Cell Lung Carcinoma; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus
      placebo in reducing or preventing the need for transfusions in anemic patients with cancer
      receiving chemotherapy, and to investigate possible quality-of-life benefits associated with
      the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red
      blood cell production.
    

Detailed description: 
      Cancer patients often experience anemia due to the disease itself, chemotherapy, or both.
      Quality of life is also affected, in part because of the fatigue associated with anemia.
      Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level
      may improve quality of life and help patients live longer. This study is a 12-week,
      double-blind, placebo-controlled multicenter study to compare the ability of epoetin alfa and
      placebo in reducing or preventing anemia and transfusions, and to investigate quality-of-life
      benefits associated with the use of epoetin alfa in patients receiving chemotherapy for
      selected cancers. During the double-blind period there will be two groups of patients: one
      group receiving epoetin injections under the skin 3 times per week (starting at 150 units per
      kilogram, adjusted if needed to a maximum of 300 units per kilogram) and other group
      receiving injections under the skin of a placebo of matching appearance and volume. If
      hemoglobin rises above 140 grams per liter (women) or 150 grams per liter (men), the dose
      will be adjusted to keep hemoglobin within a target range. A 12-week open-label extension of
      the study will be available to all patients completing the 12-week comparison period. The
      primary measure of effectiveness is determined by the proportion of patients with no
      transfusions after the first month. Additional measures of effectiveness include: the
      proportion of responders, the change of hemoglobin unrelated to transfusion, cumulative
      transfusion rate and proportion of patients transfused during the double-blind phase
      (excluding the first month), as well as the mean change over the study period in scores for
      energy, activity and overall quality of life. The results will be analyzed separately for
      non-platinum-containing chemotherapy and for different tumor types. Safety evaluations
      include assessments of the incidence and severity of adverse events, clinical laboratory
      tests, vital sign measurements, and physical examinations. The hypothesis of the study is
      that epoetin alfa is superior to placebo in improving anemia, reducing the number of
      transfusions, and improving quality of life. Epoetin alfa 150 units (U) per kilogram (kg) or
      placebo, injected under the skin 3 times weekly for 4 weeks; then either continued at 150
      U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks.
      Open-label (12 weeks): dose to maintain target hemoglobin range.
    

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: cancer; malignancy; red cell transfusion; epoetin alfa; epoetin; erythropoietin; red blood cells