An Efficacy and Safety Study of Epoetin Alfa (PROCRIT) Initiated at 40,000 Units Every Week Versus 80,000 Units Every Two Weeks in Anemic Patients With Cancer Receiving Chemotherapy.

Launched by JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, L.L.C. · Sep 13, 2005

Keywords

ClinConnect Summary

This is a randomized, open-label, multi-center study to compare end of study hemoglobin level between Epoetin alfa (PROCRIT) at 40,000 units administered subcutaneously once every week (qw) and at 80,000 units subcutaneously every two weeks (q2w) in approximately 280 anemic patients with cancer receiving chemotherapy. The study hypothesis is that a dosing regimen of PROCRIT 80,000 Units q2w subcutaneously (sc) is non-inferior to a dosing regimen of PROCRIT 40,000 Units qw sc with respect to the change in hemoglobin (Hb) from baseline to Study Week 13 for patients with chemotherapy associate...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed diagnosis of non-myeloid malignancy
• • Baseline hemoglobin value of \<= 11 g/dL unrelated to transfusion
• • Planned chemotherapy for a minimum of 12 weeks during the study
• • Life expectancy of \>= 6 months
• • ECOG Performance Status 0-2
• Exclusion Criteria:
• • Diagnosis of a myeloid malignancy or known history of myelodysplasia
• • Planned non-palliative radiation during the study
• • Anemia due to factors other than cancer/chemotherapy
• • Prior treatment with Epoetin alfa or any other erythropoietic agent within the previous three months
• • History of uncontrolled cardiac arrhythmias or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder