A Pilot Study to Evaluate the Response Rate of PROCRIT� (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Cancer Patients Not Receiving Chemotherapy Or Radiation Therapy
This was an open-label (doctors and patients knew which drug was being administered),
non-randomized (patients were assigned to treatment), multi-center pilot study with the
objective to investigate the effectiveness of PROCRIT (Epoetin alfa) on hematopoietic
response (effect on red blood cells) when administered at 60,000 Units subcutaneously (under
the skin) every two weeks in anemic patients with cancer who were not receiving chemotherapy
or radiation therapy.
Treatment with study drug was for a maximum of 12 weeks followed by a 4-week observation
period after the last dose of the study drug had been administered.
Safety and efficacy evaluations were performed at specified intervals throughout the study
and included assessment of laboratory tests (Complete Blood Count [CBC], Serum Chemistry
[including hemoglobin level]), vital signs (such as blood pressure), physical examinations
and the occurrence and severity of adverse events. All patients enrolled in this study
received pharmacologic ferrous sulfate 325 mg by mouth once a day or an equivalent
formulation, as tolerated, unless it was determined by the physician that the patient should
not receive it. All patient's received injections of PROCRIT (Epoetin alfa) 60,000 Units
under the skin once every two weeks. If after 4 weeks of treatment, the patient's hemoglobin
level did not increase by >= 1 g/dL, the Epoetin alfa dose was increased to 80,000 Units
every 2 weeks. Study drug was administered for a maximum of 12 weeks followed by a 4-week
observation period after the last dose of study drug. Epoetin alfa doses were reduced or
held as needed depending on the patients' hemoglobin level.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint was to evaluate hematopoietic response, defined as >= 2 g/dL Hb increase from baseline and/or Hb >= 12 g/dL over the course of the study and independent of transfusion within 28 days.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration