Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy

• Status: Completed
• Trial end date: 1998-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer on non-platinum chemotherapy, and to investigate 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 non-myeloid malignancy

• undergoing treatment with non-platinum-containing chemotherapy, or non-platinum-containing chemotherapy is imminent

• Eastern Cooperative Oncology Group (which is a scale used by researchers to represent the level of activity that a patient is capable of) 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 <= 10.5 grams per deciliter (or a fall in hemoglobin level >= 1.5 grams per deciliter per cycle or per month since the beginning of the current course of chemotherapy such that it dropped to <= 12 grams per deciliter) and baseline count of <125,000 microliters for developing red cells

Exclusion Criteria:

• Patients having a clinically significant disease other than cancer

• treated by platinum-containing chemotherapy within 3 months of study start

• having uncontrolled high blood pressure, a history of seizure, or untreated iron, folate, or Vitamin B12 deficiency

• received a transfusion or radiotherapy within 2 weeks of study start, or had surgery within 1 week of study start

• intending to use steroid drugs during the study