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

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00236951
First received: October 10, 2005
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Marc Tokars, Senior Director of Clinical Operations, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00236951     History of Changes
Other Study ID Numbers: 1VEN02023
Study First Received: October 10, 2005
Results First Received: June 24, 2009
Last Updated: May 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
Anemia
Cancer
Chemotherapy

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

ClinicalTrials.gov processed this record on April 15, 2014