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
| Sponsors |
Lead Sponsor: Watson Pharmaceuticals |
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| Source | Watson Pharmaceuticals | |||||||||||||||||||||||||||||||||
| 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. |
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| Overall Status | Completed | |||||||||||||||||||||||||||||||||
| Start Date | May 2002 | |||||||||||||||||||||||||||||||||
| Completion Date | December 2003 | |||||||||||||||||||||||||||||||||
| Primary Completion Date | December 2003 | |||||||||||||||||||||||||||||||||
| Phase | Phase 4 | |||||||||||||||||||||||||||||||||
| Study Type | Interventional | |||||||||||||||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 180 | |||||||||||||||||||||||||||||||||
| Condition | ||||||||||||||||||||||||||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Sodium ferric gluconate, ferrous sulfate, standard of care |
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| Eligibility |
Criteria:
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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Overall Official |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
February 2012 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | |||||||||||||||||||||||||||||||||
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: None (Open Label) |
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