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

Completed · Phase 4

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00224068

Run by

Watson Pharmaceuticals

People needed

180

Starts

2002-05-01

Expected to finish

2003-12-01

Last updated by the study team

2012-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Highly elevated TSAT or ferritin
• Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
• Medical conditions that would confound the efficacy evaluation

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Norwich, Connecticut, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Hutchinson, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Saint Joseph, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — Duluth, Minnesota, United States
• Study site — Greenwood, Mississippi, United States
• Study site — Cherry Hill, New Jersey, United States
• Study site — Denville, New Jersey, United States
• Study site — Manhasset, New York, United States
• Study site — Bismarck, North Dakota, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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