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Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia

Anemia Clinical Trial

Official title:
A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy

Clinical Trial Summary

The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic cancer patients receiving chemotherapy.

Clinical Trial Description

Chemotherapy related anemia occurs in a majority of cancer patients and can cause impaired treatment outcomes, increased treatment-related complications and altered quality of life. Epoetin alfa administered on a weekly dosing schedule of 40,000 Units subcutaneously ([SC], under the skin) with dose adjustments based on hematologic response produces significant improvement in hemoglobin levels, decreased transfusion frequency and improved quality of life. It is unknown if the recently developed agent, darbepoetin alfa, administered on an every other week fixed dose will produce similar improvements in hematologic and quality of life outcomes. Thus, further randomization studies are warranted utilizing once weekly dosing (QW) of Epoetin alfa compared to once every other week (Q2W) darbepoetin alfa. Patients will receive study medications for up to 16 weeks.Safety & efficacy evaluations will be performed at specified intervals throughout the study.The study hypothesis is that the Week 5 hemoglobin response rate in the Epoetin alfa group is better than that in the Darbepoetin alfa group. The starting dose for study drug is either Epoetin alfa (PROCRIT) 40,000 Units SC QW or Darbepoetin alfa (ARANESP) 200 mcg SC Q2W. Doses may be adjusted depending on the patient's hemoglobin levels up a maximum of 60,000 IU SC QW Epoetin alfa or 300 mcg SC Q2W Darbepoetin alfa. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00315484
Study type Interventional
Source Ortho Biotech Products, L.P.
Contact
Status Completed
Phase Phase 4
Start date February 2003
Completion date October 2004
View Details
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