Status:
COMPLETED
Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 anemi...
Eligibility Criteria
Inclusion
- 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
- Highly elevated TSAT or ferritin
- Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
- Medical conditions that would confound the efficacy evaluation
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00224068
Start Date
May 1 2002
End Date
December 1 2003
Last Update
March 2 2012
Active Locations (32)
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1
Bakersfield, California, United States
2
Chula Vista, California, United States
3
Long Beach, California, United States
4
Los Angeles, California, United States