Overview

Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy

Status:
Completed
Trial end date:
2003-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study evaluates the safety and efficacy of FerrlecitĀ® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Watson Pharmaceuticals
Treatments:
Epoetin Alfa
Ferric Compounds
Ferric gluconate
Iron
Criteria
Inclusion Criteria:

- Diagnosis of nonmyeloid malignancy

- Moderate to severe anemia

- Adequate iron stores as measured by either TSAT or ferritin

- About to start cycle of chemotherapy

- Eligible for epoetin alfa therapy

Exclusion Criteria:

- Highly elevated TSAT or ferritin

- Recent transfusion, epoetin alfa, darbepoetin or intravenous iron

- Medical conditions that would confound the efficacy evaluation