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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bakersfield, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium ferric gluconate, ferrous sulfate, standard of care

Drug

Primary outcomes

Change in hemoglobin

Secondary outcomes

Change in various iron indices

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Sep 22, 2005
Registry last updated: Mar 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed