The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy

• Status: Completed
• Trial end date: 1998-05-01
• 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 reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Confirmed diagnosis of multiple myeloma, lymphoma, breast cancer, ovarian cancer, small-cell lung cancer, esophagus cancer, or prostate cancer

• receiving treatment with chemotherapy, with at least 3 additional months of chemotherapy planned

• 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)

• life expectancy of at least 6 months

• baseline hemoglobin <12 grams per deciliter and baseline count of <100,000 microliter for developing red cells

Exclusion Criteria:

• Clinically significant disease other than cancer

• evidence of uncontrolled hypertension or history of seizure

• transfusion within 1 week of the study

• radiotherapy within 2 weeks of study start

• use of corticosteroid or steroid drugs during the study.