A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
18 Years
N/A
Both
Anemia
Trial Information
A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
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.
Inclusion Criteria:
- Histological Diagnosis of Cancer
- Hgb
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
Outcome Description:
The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
Outcome Time Frame:
During Stage 2 (week 9 through week 21)
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
1VEN02023
NCT ID:
NCT00236951
Start Date:
February 2003
Completion Date:
December 2005
Related Keywords:
- Anemia
- Anemia
- Cancer
- Chemotherapy
- Anemia
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