Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Epoetin Alfa; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

• Histological Diagnosis of Cancer

• Hgb
• Ongoing or Planned Chemotherapy

• Body Weight >50kg

• Free of Active Infection

• Karnofsky Status 60% to 100%

Exclusion Criteria:

• Active infection

• Use of Multivitamins with iron within one week of entry

• Myelophthisic bone marrow involvement by tumor except hematologic malignancy

• Concurrent medical condition that would prevent compliance or jeopardize the health of the patient

• Use of any IV iron products within two months of study entry

• Blood Transfusions

• Hypoplastic bone marrow failure state

• Acute Leukemia

• Myeloproliferative syndrome

• Uncontrolled hypertension