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

A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit® in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00224068

Enrollment

180

Registered

2005-09-22

Start date

2002-05-31

Completion date

2003-12-31

Last updated

2012-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Iron deficiency, Sodium ferric gluconate, anemia, cancer chemotherapy, epoetin alfa, Anemia/drug therapy, Anemia, Iron-Deficiency/drug therapy/etiology, Hematinics/administration & dosage/pharmacology, Antineoplastic Agents/adverse effects, Erythropoietin, Recombinant/therapeutic use/adverse effects

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.

Interventions

DRUGSodium ferric gluconate, ferrous sulfate, standard of care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin	—

Secondary

Measure	Time frame
Change in various iron indices	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026