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

NCT ID: NCT00236951

Last Updated: 2018-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2005-12-31

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Venofer + erythropoietin (responders)

Group Type: ACTIVE_COMPARATOR

iron sucrose injection USP

Intervention Type: DRUG

erythropoietin only (responders)

Group Type: ACTIVE_COMPARATOR

stable erythropoietin therapy

Intervention Type: DRUG

Venofer+erythropoietin(non-responders)

Group Type: ACTIVE_COMPARATOR

iron sucrose injection USP

Intervention Type: DRUG

erythropoietin only (non-responders)

Group Type: ACTIVE_COMPARATOR

stable erythropoietin therapy

Intervention Type: DRUG

Interventions

iron sucrose injection USP

Intervention Type: DRUG

stable erythropoietin therapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Luitpold Pharmaceuticals, Inc.

Other Identifiers

1VEN02023

Identifier Type: -

Identifier Source: org_study_id