An Efficacy and Safety Study of PROCRIT (Epoetin Alfa) in Cancer Patients Receiving Chemotherapy Every Week or Every Four Weeks

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness and safety of epoetin alfa at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL (Initiation Phase), followed by a dose of 60,000 U once every other week (Q2W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of non-myeloid malignancy and receiving chemotherapy

• Baseline Hb of <= 11 g/dL

• Planned chemotherapy for a minimum of 16 weeks to be administered weekly or every 4 weeks

• Female patients with reproductive potential must have a negative serum pregnancy test at screening.

Exclusion Criteria:

• No uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, or thrombosis

• No transfusion of white blood cells or packed red blood cells within 28 days of Epoetin alfa treatment

• No prior treatment with Epoetin alfa or any other erythropoetic agent within the previous three months