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

Phase 2 Completed 115 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Ortho Biotech Products, L.P. · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the effectiveness and safety of PROCRIT (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 80,000 Units once every three weeks (Q3W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.

Timeline

Start: 2003-03
Primary completion: —
Completion: 2005-01

Publications

Results Montoya VP, Xie J, Williams D, Woodman RC, Wilhelm FE. An extended maintenance dosing regimen of epoetin alfa 80,000 U every 3 weeks in anemic patients with cancer receiving chemotherapy. Support Care Cancer. 2007 Dec;15(12):1385-92. doi: 10.1007/s00520-007-0263-6. Epub 2007 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	80000 iu	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications