An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Weekly or Every Four Week Regimen
Epoetin alfa administered three times weekly (150 U/kg) or once weekly (40,000 U) results in
a response rate (defined as >= 2 g/dL hemoglobin (Hb) increase or Hb >= 12 g/dL) of
approximately 65% of anemic chemotherapy patients and produces a mean hemoglobin rise of 1.8
g/dL. Higher weekly dosing may result in a higher response rate and a more timely mean
hemoglobin rise while remaining safe. Additionally, limited data are available to show
whether epoetin alfa maintenance therapy can be administered less frequently than weekly and
still maintain hemoglobin levels. This is an open label, multicenter, non-randomized study
to determine the safety and effectiveness of epoetin alfa given to cancer patients receiving
chemotherapy every week or every four weeks.
Patients will receive up to 12 injections of epoetin alfa 60,000 U once every week (QW)
subcutaneously (under the skin) for up to 12 weeks. Once a patient's hemoglobin level (Hg)
has reached a target level of 12 g/dL, they will begin the Maintenance Phase. Patients who
qualify for Maintenance Phase will receive up to 6 injections of 60,000 U every other week
(Q2W) epoetin alfa under the skin for up to an additional 12 weeks to maintain hemoglobin
11.5 g/dL during chemotherapy administration. Doses will be held and adjusted downward if
hemoglobin level rises to >13 g/dL or if a very rapid hemoglobin response occurs (e.g., an
increase of more than 1.3 g/dL in a 2-week period).
Safety evaluations include clinical laboratory tests (hemoglobin and hematocrit), vital sign
measurements (blood pressure), and incidence and severity of adverse events. In addition,
the incidence of anti-erythropoietin antibodies at baseline and study completion/early
withdrawal will be evaluated in patients who receive multiple doses of PROCRIT (Epoetin
alfa). Patients will receive up to 12 injections of 60,000 U once every week (QW) epoetin
alfa subcutaneously (under the skin) for up to 12 weeks. Once a patient's hemoglobin level
(Hg) has reached a target level of 12 g/dL, they will begin the Maintenance Phase. Patients
who qualify for Maintenance Phase will receive up to 6 injections of 60,000 U every other
week (Q2W) epoetin alfa under the skin for up to an additional 12 weeks to maintain
hemoglobin 11.5 g/dL during chemotherapy administration.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients achieving >= 2 g/dL Hb increase from baseline or Hb >= 12 g/dL in the Initiation Phase (up to 12 weeks).
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
CR004615
NCT00337948
February 2003
February 2005
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