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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: iron sucrose injection USP; Drug: stable erythropoietin therapy

• Registration Number: NCT00236951
• Lead Sponsor: American Regent, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-10
• Study First Submitted: 2005-10-10
• Study First Submitted QC: 2005-10-10
• Study First Posted: 2005-10-12
• Study Completion: 2005-12
• Results First Submitted: 2009-06-24
• Results First Submitted QC: 2009-08-14
• Results First Posted: 2009-09-23
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venofer + erythropoietin (responders)	iron sucrose injection USP	-
erythropoietin only (non-responders)	stable erythropoietin therapy	-
erythropoietin only (responders)	stable erythropoietin therapy	-
Venofer+erythropoietin(non-responders)	iron sucrose injection USP	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).	During Stage 2 (week 9 through week 21)	The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).