Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer

Summary

RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy. PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.

Timeline

Start

2006-01

Primary completion

2009-03

Completion

2009-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); DA + IV Iron vs DA + Placebo; p = 0.39; Fisher Exact NCT00661999 ↗

registry analysis (superiority or other test); DA + Oral Iron vs DA + Placebo; p = 0.73; Fisher Exact NCT00661999 ↗

Drugs

Indications