Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

Summary

RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia. PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.

Timeline

Start

2003-08

Primary completion

2003-11

Completion

—

Outcome

Met primary endpoint

paper noninferiority was concluded because the upper 95% CI limit of the difference between groups (10.8%) was below the prespecified noninferiority margin. PMID 16710026 ↗

Publications

• Results 20030125 Study Group Trial; Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol. 2006 May 20;24(15):2290-7. doi: 10.1200/JCO.2005.03.8570.

Drugs

Indications