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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: stable erythropoietin therapy; Drug: iron sucrose injection USP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00236951

1VEN02023

Details and patient eligibility

About

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.

Full description

This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological Diagnosis of Cancer
• Hgb </= 10
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 4 patient groups

Venofer + erythropoietin (responders)

Active Comparator group

Treatment:

Drug: iron sucrose injection USP

erythropoietin only (responders)

Active Comparator group

Treatment:

Drug: stable erythropoietin therapy

Venofer+erythropoietin(non-responders)

Active Comparator group

Treatment:

Drug: iron sucrose injection USP

erythropoietin only (non-responders)

Active Comparator group

Treatment:

Drug: stable erythropoietin therapy