A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin Alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy
This is an open-label (both the researcher and the patient in the study know the treatment
that is being given), non-randomized, multi-center pilot study with the objective to
investigate the efficacy of PROCRIT (Epoetin alfa) with regard to hematopoietic response
when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic
patients with cancer not receiving chemotherapy or radiation therapy. Hematological
laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence
and severity of adverse events will be assessed throughout the study. Patients will receive
a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every
week for a maximum of 13 weeks. Doses may be reduced depending on the patients' hemoglobin
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.
Ortho Biotech Products, L.P. Clinical Trial
Ortho Biotech Products, L.P.
United States: Institutional Review Board