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

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ClinicalTrials.gov Identifier: NCT00236951
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : September 23, 2009
Last Update Posted : February 20, 2018
Sponsor:
Information provided by:
Luitpold Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: iron sucrose injection USP Drug: stable erythropoietin therapy Phase 3

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  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : February 2003
Primary Completion Date : October 2005
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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).



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

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 Posted: October 12, 2005    Key Record Dates
Results First Posted: September 23, 2009
Last Update Posted: February 20, 2018
Last Verified: January 2018

Keywords provided by Luitpold Pharmaceuticals:
Anemia
Cancer
Chemotherapy

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