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

Phase 4

Completed

• Conditions: Anemia

• Registration Number: NCT00224068
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

This study evaluates the safety and efficacy of Ferrlecit® (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin

Secondary Outcome Measures

Name	Time	Method
Change in various iron indices