An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa (PROCRIT�) Versus No/Delayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression (Anemia)
The purpose of this study is to evaluate hematologic response in patients receiving epoetin
alfa (PROCRIT®) therapy for persistent chemotherapy-induced myelosuppression (anemia) after
completion of chemotherapy administration as compared to patients who do not receive weekly
epoetin alfa (PROCRIT®) immediately after cessation of chemotherapy. Further, the duration
of treatment necessary to achieve these endpoints will be studied. A No/Delayed epoetin
alfa (PROCRIT®) treatment control (whereby patients in the control group will receive
epoetin alfa (PROCRIT®) if their Hb decreases to < 10g/dL during the study) will be used to
establish the frequency and magnitude of changes in clinical end points that may occur when
epoetin alfa (PROCRIT®) treatment is not continued (or started) for patients with residual
myelosuppression after chemotherapy administration has ended. A 2:1 randomization will be
used to give every patient a greater chance to receive immediate treatment (66.6% epoetin
alfa (PROCRIT®) treatment vs. 33.3% No/Delayed epoetin alfa (PROCRIT®) treatment). The
study will be powered to show differences between the two groups in hematologic response.
In this study, the hematologic response is defined as the proportion of patients who are
transfusion-free and are able to maintain their mean Hb level at >= 11 g/dL during the study
without a Hb drop to <= 10 g/dL and/or transfusion.
The study hypothesis was that immediate epoetin alfa (PROCRIT®) treatment would be more
effective in treatment of anemia than No/Delayed epoetin alfa (PROCRIT®) treatment in
patients with cancer and persistent chemotherapy-induced anemia. Patients will be
randomized 2:1 to receive epoetin alf or no epoetin treatment. The starting dose will be
40,000 Units weekly (QW) or the dose they were on prior to the study (30,000-60,000 Units
QW). If the Hb level decreases to <= 10 g/dL, PROCRIT will be initiated at a dose of 40,000
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary efficacy endpoint is hematologic response, defined as follows: Transfusion free during study, and the average of post baseline Hb values > 11 g/dL without a post baseline Hb < 10 g/dL.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration