A Pilot Study to Evaluate the Response Rate of Epoetin Alfa (PROCRIT) at 80,000 Units Every Three Weeks in Anemic Patients With Cancer Not Receiving Chemotherapy or Radiation Therapy
The current approved dosage for epoetin alfa is 40,000 Units once per week with an
escalation to 60,000 Units once per week if the response is inadequate after four weeks of
treatment at 40,000 Units. This dosing scheme, while proven to be efficacious, is often
inconvenient for both patients and medical personnel. This is an open-label, non-randomized,
multi-center pilot study with the objective to investigate the efficacy of epoetin alfa
(PROCRIT®) with regard to hematopoietic response when administered at 80,000 Units
subcutaneously every three weeks in anemic patients with cancer not receiving chemotherapy
or radiation therapy. Patients will receive two epoetin alfa injections (40,000 Units per
injection) under the skin once every three weeks for a maximum of 13 weeks, totalling a
maximum of four treatments. Doses may be reduced depending on the patients' hemoglobin
level.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent of patients that achieved a hematopoietic response, defined as a Hb increase >= 2 g/dL and/or Hb = 12 g/dL during the study independent of transfusion within 28 days
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration
CR003223
NCT00210587
February 2005
December 2005
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