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

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

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.

• 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 cancer (except for rapid onset of severe leukemia and malignancies of the bone marrow and spleen) and anemia resulting from non-cisplatin-containing chemotherapy who are receiving cyclic chemotherapy for <=5 consecutive days every 3 or 4 weeks (for 3 cycles of chemotherapy)

• having a Performance score of 0, 1, 2, or 3 (patients' ability to perform daily activities, a self-care performance score of 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

• with signs and symptoms of physical stability for 1 month before the study, (based on physical examination including vital signs, weight, and electrocardiogram), not grossly obese, and having a hemoglobin <= 10.5 grams/deciliter (g/dL)

• who are able to demonstrate the ability to administer self-injections

Exclusion Criteria:

• Patients with a history of any blood disease

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

• having a spread of cancer to the brain

• having uncontrolled high blood pressure, an iron, folate or vitamin B12 deficiency, or a history of seizures

• received therapy with androgen within 2 months before the start of study, received radiation therapy or surgery to decrease the number of cancer cells within 30 days before the start of the study, or experienced sudden and severe onset of illness within 7 days before the start of the study