A Pilot Study to Evaluate the Hematologic Response Rate of PROCRIT� (Epoetin Alfa) at 80,000 Units Once Weekly in Anemic Cancer Patients Receiving Chemotherapy
When comparing the proposed study dose to current literature, the initial study dose of
80,000 Units administered once per week is equivalent to an individual dose of 1142 Units/kg
body weight for a 70 kg patient. It is also common in clinical practice for anemic cancer
patients to be treated with a dose of PROCRIT (Epoetin alfa) of 40,000 Units weekly. This
study was an open-label, non-randomized pilot study of cancer patients with non-myeloid
malignancies with a hemoglobin < = 11 g/dL planned to receive at least 12 weeks of
chemotherapy. The objective of the study was to evaluate the hematologic response, safety,
and clinical outcomes of PROCRIT (Epoetin alfa) at 80,000 Units given subcutaneously (under
the skin) once weekly in anemic cancer patients receiving chemotherapy. If, at any time the
hemoglobin was > 13 g/dL, PROCRIT (Epoetin alfa) therapy was held until the hemoglobin was
<= 12 g/dL, then resumed at 60,000 Units once weekly. The dose was also reduced if the
hemoglobin rose by > 1.3 g/dL in a 2 week period.
Additionally, the incidence of anti-erythropoietin antibodies at baseline and at end of
study/early withdrawal in study patients who have received a minimum of two or more doses of
PROCRIT (Epoetin alfa) over at least a one-month period was evaluated. Rarely, antibodies to
erythropoietin may form in patients who have some types of diseases (e.g., autoimmune
diseases, rheumatoid arthritis, anemia of chronic disease) or in response to exposure to
erythropoietin products such as Epoetin alfa necessitating discontinuation of the
erythropoietin agent and medical treatment that may include blood transfusions. Hemoglobin
level, vital signs (blood pressure) and occurrence and severity of adverse events was
assessed throughout the study. PROCRIT (Epoetin alfa) was given at a dose of 80,000 Units
subcutaneously (under the skin) for 12 weeks. The PROCRIT (Epoetin alfa) dose was monitored
throughout the study and the dose was withheld or reduced as necessary to maintain
hemoglobin level and rate of hemoglobin rise.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary efficacy endpoint was major response defined as the proportion of patients with >= 2 g/dL hemoglobin (Hb) increase from baseline or Hb >= 12 g/dL 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