A Study of PROCRIT (Epoetin Alfa) 80,000 Units (U) Once Every Four Weeks (Q4W) vs. 40,000 U Once Every Two Weeks (Q2W) in Cancer Patients Not Receiving Chemotherapy
The purpose of this study is to assess the safety and effectiveness of PROCRIT (Epoetin alfa) administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once every four weeks or 40,000 U once every two in anemic patients with cancer not receiving chemotherapy or radiation therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT (Epoetin Alfa) 80,000 Units Once Every Four Weeks (Q4W) vs. 40,000 Units Once Every Two Weeks (Q2W) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)|
- The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.
- Secondary objectives are to assess the two dosing regimens on time-to-hematopoietic response and transfusion requirements. Safety assessments will include laboratory tests, blood pressure, physical examination and severity of adverse events.
|Study Start Date:||March 2006|
|Study Completion Date:||May 2007|
Epoetin alfa is an analogue (has the identical amino acid sequence) of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. Although epoetin alfa has been known to be effective in treatment of anemia associated with cancer chemotherapy, there are no specific formal guidelines on the use of epoetin alfa for the treatment of anemia in cancer patients not receiving chemotherapy or radiation therapy. Several prospective clinical trials investigating the efficacy of epoetin alfa in cancer-associated anemia included groups of patients not receiving chemotherapy where it was demonstrated that the use of epoetin alfa in this population was safe and effective in increasing hemoglobin (Hb) levels and reducing transfusion requirements. The optimal dosing regimen of epoetin alfa in cancer patients not receiving chemotherapy or radiation therapy remains unclear.
This 17-week study is a prospective, randomized, open-label, multi-center study to assess the safety and effectiveness of epoetin alfa in anemic patients with cancer not receiving chemotherapy or radiation therapy. Eligible patients with hemoglobin level <= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks. The study hypothesis are that there are no long-term safety concerns of epoetin alfa administered at these two dosing regimens and that both dosing regimens are equally effective in this patient population. Eligible patients with hemoglobin levels <= 11 g/dL will receive epoetin alfa 40,000 U once every 2 weeks for 15 weeks or 80,000 U once every 4 weeks for 13 weeks.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|