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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
iron sucrose injection USP
stable erythropoietin therapy
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anemia focused on measuring Anemia, Cancer, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Venofer + erythropoietin (responders)

    erythropoietin only (responders)

    Venofer+erythropoietin(non-responders)

    erythropoietin only (non-responders)

    Arm Description

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2005
    Last Updated
    January 22, 2018
    Sponsor
    American Regent, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00236951
    Brief Title
    Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    October 2005 (Actual)
    Study Completion Date
    December 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    American Regent, Inc.

    4. Oversight

    5. Study Description

    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 agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia
    Keywords
    Anemia, Cancer, Chemotherapy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    224 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Venofer + erythropoietin (responders)
    Arm Type
    Active Comparator
    Arm Title
    erythropoietin only (responders)
    Arm Type
    Active Comparator
    Arm Title
    Venofer+erythropoietin(non-responders)
    Arm Type
    Active Comparator
    Arm Title
    erythropoietin only (non-responders)
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    iron sucrose injection USP
    Intervention Type
    Drug
    Intervention Name(s)
    stable erythropoietin therapy
    Primary Outcome Measure Information:
    Title
    Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
    Description
    The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
    Time Frame
    During Stage 2 (week 9 through week 21)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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