A Study to Determine the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Patients With Persistent Anemia Caused by Advanced Cancer

• Status: Completed
• Trial end date: 1990-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of epoetin alfa versus placebo, injected beneath the skin, in the treatment of patients with persistent anemia caused by advanced cancer, with a below normal hematocrit of <= 37%. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients with advanced cancer (except for rapid onset of severe leukemia and malignancies of the bone marrow and spleen) which is resistant to treatment or cure with chemotherapy or for which there is no established effective chemotherapy

• having persistent anemia as determined by a low hematocrit of <=37% and a negative direct Coombs' test (a blood test used to detect proteins and especially certain antibodies produced abnormally by some cancer cells on the surface of red blood cells)

• having a Performance score of 0, 1, 2, or 3 (patients' ability to perform daily activities, a score ranging from 0 [fully active, no disease restriction] to 3 [capable of only limited self-care, confined to bed or chair more than 50% of waking hours])

• having a life expectancy of at least 3 months

• who have not had chemotherapy to decrease cells and or radiation therapy within 1 month before the start of the study

Exclusion Criteria:

• Patients who have a history of any primary blood disease

• having signs and symptoms of significant disease/dysfunction not caused by the underlying cancer

• having an iron, folate, or vitamin B12 deficiency, or signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment

• having significant bleeding of the stomach and/or intestines, uncontrolled high blood pressure, a history of seizures, or a sudden onset of severe illness within 7 days before the start of the study

• received androgen therapy within 2 months before the start of the study or have used medications known to affect the hematocrit within 1 month before the start of the study