Overview

A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Patients With Persistent Anemia as a Result of Cancer Treatment With Cisplatin, a Platinum-containing Chemotherapy Drug

Status:
Completed
Trial end date:
1990-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in the treatment of persistent anemia caused by advanced cancer and aggressive cisplatin 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:
Cisplatin
Epoetin Alfa
Criteria
Inclusion Criteria:

- Patients with cancer (except for rapid onset of severe leukemia and malignancies of
the bone marrow and spleen) and having anemia resulting from cisplatin-containing
chemotherapy

- receiving cyclic chemotherapy for <=5 consecutive days every 3 or 4 weeks (for 3
cycles of chemotherapy)

- Performance score of 0, 1, 2, or 3 (grades assessing patients' ability to perform
daily activities)

- having a life expectancy of at least 3 months

- having a hemoglobin level <= 10.5 grams/deciliter, and signs and symptoms of physical
stability for 1 month before the study (based on physical examination including vital
signs, weight, and electrocardiogram)

- with an 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

- receiving radiation therapy or surgery to decrease the number of cancer cells within
30 days before the start of the study

- having a sudden and severe onset of illness within 7 days before the start of the
study

- having cancer that has spread to the brain, a history of seizures, uncontrolled high
blood pressure, or an iron, folate, or vitamin B12 deficiency