Status:
COMPLETED
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
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 age...
Eligibility Criteria
Inclusion
- Histological Diagnosis of Cancer
- Hgb \</= 10
- Ongoing or Planned Chemotherapy
- Body Weight \>50kg
- Free of Active Infection
- Karnofsky Status 60% to 100%
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00236951
Start Date
February 1 2003
End Date
December 1 2005
Last Update
February 20 2018
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