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

January 22, 2018 updated by: American Regent, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Venofer + erythropoietin (responders)
Drug: iron sucrose injection USP
Active Comparator: erythropoietin only (responders)
Drug: stable erythropoietin therapy
Active Comparator: Venofer+erythropoietin(non-responders)
Drug: iron sucrose injection USP
Active Comparator: erythropoietin only (non-responders)
Drug: stable erythropoietin therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Regent, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

October 1, 2005

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

October 10, 2005

First Submitted That Met QC Criteria

October 10, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1VEN02023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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