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

Watson Pharmaceuticals180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Anemia

Interventions

Sodium ferric gluconate, ferrous sulfate, standard of careDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (32)

Unnamed facility

Bakersfield, California, United States

Outcomes

Primary Outcomes

Change in hemoglobin

Secondary Outcomes

Change in various iron indices

Data from ClinicalTrials.gov

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