Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.
This is a randomized, open-label, multi-center study. Eligible patients will be identified
during the screening phase. After randomization, the Treatment Phase will start at the Day
1, Week 1 visit. The entire study period will be up to 22 weeks, with the screening phase
lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four
weeks. The primary objective of this study is to obtain efficacy and safety data regarding
PROCRIT (Epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three
weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy:
1. Early Intervention Group: PROCRIT (Epoetin alfa) treatment started at patient
hemoglobin (Hb) >= 11.0 g/dL to <= 12.0 g/dL and
2. Standard Intervention Group: PROCRIT (Epoetin alfa) treatment started once patient
hemoglobin drops to < 11 g/dL or has a Hb <11.0 g/dL at study entry.
For safety monitoring, all patients will be followed for adverse events, hemoglobin (Hb),
hematocrit (Hct), blood chemistries and blood pressure measurements throughout the study.
All eligible patients with hemoglobin < 12.0 g/dL will be randomized to receive Epoetin alfa
injections (120,000 Units ) under the skin every 3 weeks for a maximum of 16 treatment
weeks. Doses may be adjusted depending on the patients hemoglobin levels.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of weekly hemoglobin levels for all patients in each group during the 16 week PROCRIT (Epoetin alfa) treatment that are > 11.0 g/dL and < 13.0 g/dL.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration