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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 12, 2005
Last Update Posted: May 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Luitpold Pharmaceuticals
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.

Condition Intervention Phase
Anemia Drug: iron sucrose injection USP Drug: stable erythropoietin therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • 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).

Enrollment: 224
Study Start Date: February 2003
Estimated Study Completion Date: December 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Marc Tokars, Senior Director of Clinical Operations, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00236951     History of Changes
Other Study ID Numbers: 1VEN02023
First Submitted: October 10, 2005
First Posted: October 12, 2005
Results First Submitted: June 24, 2009
Results First Posted: September 23, 2009
Last Update Posted: May 11, 2010
Last Verified: May 2010

Keywords provided by Luitpold Pharmaceuticals:

Additional relevant MeSH terms:
Hematologic Diseases
Ferric oxide, saccharated
Epoetin Alfa
Trace Elements
Growth Substances
Physiological Effects of Drugs