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

Watson Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: Sodium ferric gluconate, ferrous sulfate, standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224068

FR01008

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)