A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in Patients With Anemia as a Result of Advanced Cancer and Treatment With Aggressive Chemotherapy

Neoplasms Clinical Trial

Official title: The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Chemotherapy

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa in the treatment of persistent anemia caused by advanced cancer and aggressive adriamycin-chemotherapy. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Clinical Trial Description

Patients undergoing treatment with adriamycin-containing chemotherapy frequently develop significant anemia. Agents that can increase the amount of hemoglobin in cancer patients undergoing treatment with non-platinum-containing cyclic chemotherapy may improve the patients' reduced physical strength and reduced stamina resulting from anemia, improve the patients' ability to continue chemotherapy, and improve the patients' overall qualify of life. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin, that is used to treat anemia by stimulating red blood cell production. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. The study evaluates the safety and effectiveness of epoetin alfa in treating patients who develop persistent anemia as a result of treatment with aggressive non-platinum-containing cyclic chemotherapy for any cancer type (except rapid and severe onset of leukemias and malignancies of the bone marrow and spleen). The study consists of a screening period when patients' eligibility is determined, a 12-week double-blind treatment period when patients receive 3 injections each week with either epoetin alfa or placebo, and an optional open-label treatment period when patients who choose to continue will receive 3 injections of epoetin alfa per week during any remaining cycles of their chemotherapy. Eligible patients will be randomly assigned to one of two treatment groups: one group receiving epoetin alfa 150 units/kilogram and the other group receiving a comparable volume of placebo. Study drug is administered by injection beneath the skin 3 times weekly for 12 weeks. The dose of study medication may be increased or decreased at the discretion of the physician, based on the results of blood tests. Depending on the patient's chemotherapy cycle, he or she will return to the study site every 3 or 4 weeks for administration of study medication. Safety evaluations (laboratory tests, vital sign measurements, reporting of adverse events, physical examination, and electrocardiogram) are performed throughout the study. The primary measures of effectiveness of the study drug will be determined by the number of transfusions patients require and by changes in blood test results for hemoglobin, hematocrit, and reticulocytes (immature red blood cells) from before the start of the study to the end of the study. The study hypothesis is that epoetin alfa will, more effectively than placebo, stimulate adequate production of red blood cells to increase the hemoglobin level in cancer patients who are anemic as a result of undergoing treatment with aggressive non-platinum-containing cyclic chemotherapy. Double-blind: Epoetin alfa 150 units/kilogram (U/kg) or matching volume placebo injected beneath the skin 3 times weekly for 12 weeks. Open-label: Epoetin alfa at the dose received at the end of the double-blind study injected beneath the skin 3 times weekly for any remaining cycles of chemotherapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Neoplasms

• NCT number: NCT00266617
• Study type: Interventional
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Status: Completed
• Phase: Phase 2
• Completion date: June 1990