NCT00111137

Treatment for Patients With Non-Myeloid Malignancies Receiving Chemotherapy

A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 718 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.

Conditions

• Cancer
• Non-Myeloid Malignancies

Interventions

Type	Name	Description
DRUG	rHuEPO	rHuEPO 40,000U QW for 4 weeks. Dose will be increased to 60,000U/week at week 5 if inadequate response through week 12.
DRUG	Darbepoetin alfa	4.5 mcg/kg QW for 4 weeks then Q3W starting at week 5 through week 11.

Timeline

• Start date: 2003-02-01
• Primary completion: 2003-11-01
• Completion: 2004-04-01
• First posted: 2005-05-18
• Last updated: 2008-02-28