Spots Global Cancer Trial Database for The Duration Study

Study Description

Brief Summary: The purpose of this study is to compare the efficacy of epoetin alfa (PROCRIT®) administered subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRIT®) treatment in patients with cancer who are anemic.

Detailed Description: 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 Units QW.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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