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

Anemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224068
• Other study ID #: FR01008
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 29, 2012
• Start date: May 2002
• Est. completion date: December 2003

Study information

• Verified date: February 2012
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007 Feb;12(2):231-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin			No
Secondary	Change in various iron indices

External Links

•   Oncologist. 2007 Feb;12(2):231-42