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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

Conditions
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Anemia

Intervention / Treatment
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* Drug: iron sucrose injection USP
* Drug: stable erythropoietin therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Venofer + erythropoietin (responders)<br> | Drug: iron sucrose injection USP<br> <br> |
| Active Comparator: erythropoietin only (responders)<br> | Drug: stable erythropoietin therapy<br> <br> |
| Active Comparator: Venofer+erythropoietin(non-responders)<br> | Drug: iron sucrose injection USP<br> <br> |
| Active Comparator: erythropoietin only (non-responders)<br> | Drug: stable erythropoietin therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to the Maximum Hemoglobin Level 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). | During Stage 2 (week 9 through week 21) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Cancer, Chemotherapy