Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia
This was a retrospective chart review of patients with chemotherapy related anemia. Two
hundred (200) patients with chemotherapy related anemia were to have received PROCRIT
(Epoetin alfa) on a weekly schedule (e.g., once every week or more frequently) for at least
4 weeks, followed by a maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing
(e.g. once every 2 weeks, once every 3 weeks, or once every 4 weeks) for at least 6 weeks.
Hemoglobin response and maintenance of initial treatment phase hemoglobin with alternate
doses of PROCRIT (Epoetin alfa) were to be evaluated.Study sites were to record data in a
Case Report Form which would then be entered into a database. Data was to be recorded,
starting with the PROCRIT (Epoetin alfa) initiation phase (at least 4 weeks duration), and
extending through at least 6 weeks of maintenance therapy. A minimum of 20 study sites were
to be enrolled in the data collection process.Data obtained was to be analyzed to reflect
alternate dosing patterns of PROCRIT (Epoetin alfa) therapy. The frequency and percentage
of patients receiving each dosing regimen were to be summarized. Hemoglobin response and
maintenance of initial treatment phase hemoglobin with alternate doses of PROCRIT (Epoetin
alfa) were to be evaluated. If PROCRIT (Epoetin alfa) was discontinued, the time and
reason(s) for discontinuation were to be recorded.
Patients were to have received PROCRIT (Epoetin alfa) subcutaneous injection on a weekly
schedule (e.g., once every week or more frequently) for at least 4 weeks, followed by a
maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing (e.g. once every 2
weeks, 3 weeks, or 4 weeks) for at least 6 weeks.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency and percentage of subjects in each dosing regimen will be summarized. Hemoglobin (Hb) response and maintenance of initial treatment phase Hb with alternate doses of Epoetin alfa. Time and reasons for discontinuing Epoetin alfa.
Ortho Biotech Products, L.P. Clinical Trial
Study Director
Ortho Biotech, Inc.
United States: Institutional Review Board
CR005128
NCT00495378
November 2002
March 2003
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