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

Anemia Clinical Trial

Official title:

A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236951
• Other study ID #: 1VEN02023
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2005
• Last updated: January 22, 2018
• Start date: February 2003
• Est. completion date: December 2005

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• iron sucrose injection USP

• stable erythropoietin therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to the Maximum Hemoglobin Level 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).	During Stage 2 (week 9 through week 21)