A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy
The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard of care.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy|
- Change in hemoglobin from the start of the study to 3 or 4, 8 or 9, and 12 weeks, and at the end of the treatment period
- Number of patients who receive an allogenic blood transfusion during the study
|Study Start Date:||August 2003|
|Study Completion Date:||September 2006|
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the tiredness associated with anemia. Previous studies with epoetin alfa have suggested that early intervention with epoetin alfa results in higher hemoglobin levels and lower incidence of red blood cell transfusions than are achieved with delayed intervention. This is a randomized, open-label, explorative, sequential study that evaluates the effects of early treatment with epoetin alfa to determine its impact on hemoglobin values and the need for red blood cell transfusions as well as the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer. During their current course of chemotherapy, patients will receive either early treatment with epoetin alfa or standard treatment with epoetin alfa (epoetin alfa administered when hemoglobin is <=10 g/dL), in addition to best standard care. Best standard care during chemotherapy may include red blood cell transfusions, white cell growth factors, folic acid, and iron supplementation, as needed. Effectiveness will be determined by the number of patients who receive an allogenic blood transfusion during the study and the change in hemoglobin at 3 or 4 weeks, 8 or 9 weeks, and 12 weeks, and at the end of the treatment period. Safety evaluations (incidence of adverse events, abnormal clinical laboratory tests, and vital signs) will be performed throughout the study. The study hypothesis is that cancer patients receiving chemotherapy who receive early treatment with epoetin alfa will have higher hemoglobin levels and fewer red blood cell transfusions than cancer patients receiving chemotherapy who receive standard treatment with epoetin alfa. This study will be conducted in the Netherlands and will only enroll European patients and will be generally well-tolerated. Epoetin alfa injections (40,000 units) under skin once a week either within 7 days after start of first chemotherapy cycle or from day hemoglobin is <=10 g/dL. Patients will receive epoetin alfa during the current course of chemotherapy or up to 24 weeks. Dose may be adjusted.