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Anemia in Patients With a Non-Myeloid Malignancy

Primary Purpose

Neoplasms, Anemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Darbepoetin alfa
rHuEPO
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring anemia of cancer/chemotherapy, non-myeloid malignancies, Drug Therapy

Eligibility Criteria

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

Inclusion Criteria: Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug Screening hemoglobin concentration less than or equal to 11.0 g/dL ECOG performance status of 0 to 2 (inclusive) Exclusion Criteria: History of seizure disorder Primary hematologic disorder that could cause anemia Unstable or uncontrolled disease/condition related to or affecting cardiac function Clinical evidence of chronic infection/inflammatory disease Positive test for HIV infection Previously confirmed neutralizing antibodies to rHuEPO Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    rHuEPO

    Darbepoetin alfa

    Arm Description

    Outcomes

    Primary Outcome Measures

    Time to first hemoglobin response during the treatment period

    Secondary Outcome Measures

    Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events
    Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)
    Average weekly dosage of study drug during the 16-week treatment period
    Receiving red blood cell (RBC) transfusion from week 5 to week 12
    Change in FACT-Fatigue scale score from baseline to week 7
    Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise
    Profile of change in FACT-Fatigue scale score from baseline over the treatment period
    Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)
    Change in FACT-Physical Well-being scale score from baseline to EOTP
    Receiving RBC transfusion during the treatment period
    Number of units of RBC transfused during the treatment period
    Achieving a hemoglobin response by week 7
    Change in hemoglobin concentration from baseline to EOTP
    Time to first hematopoietic response
    Achieving a hemoglobin correction
    Number and percentage of subjects who exceed the hemoglobin concentration threshold

    Full Information

    First Posted
    May 28, 2002
    Last Updated
    September 11, 2008
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00038064
    Brief Title
    Anemia in Patients With a Non-Myeloid Malignancy
    Official Title
    A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    October 2003 (Actual)
    Study Completion Date
    April 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasms, Anemia
    Keywords
    anemia of cancer/chemotherapy, non-myeloid malignancies, Drug Therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    rHuEPO
    Arm Type
    Active Comparator
    Arm Title
    Darbepoetin alfa
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa
    Intervention Description
    Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.
    Intervention Type
    Drug
    Intervention Name(s)
    rHuEPO
    Intervention Description
    150 IU/kg TIW
    Primary Outcome Measure Information:
    Title
    Time to first hemoglobin response during the treatment period
    Time Frame
    during the treatment period
    Secondary Outcome Measure Information:
    Title
    Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events
    Time Frame
    throughout study
    Title
    Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)
    Time Frame
    throughout study
    Title
    Average weekly dosage of study drug during the 16-week treatment period
    Time Frame
    16-week treatment period
    Title
    Receiving red blood cell (RBC) transfusion from week 5 to week 12
    Time Frame
    from week 5 to week 12
    Title
    Change in FACT-Fatigue scale score from baseline to week 7
    Time Frame
    from baseline to week 7
    Title
    Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise
    Time Frame
    throughout study
    Title
    Profile of change in FACT-Fatigue scale score from baseline over the treatment period
    Time Frame
    from baseline over the treatment period
    Title
    Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)
    Time Frame
    from baseline to EOTP
    Title
    Change in FACT-Physical Well-being scale score from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Receiving RBC transfusion during the treatment period
    Time Frame
    during the treatment period
    Title
    Number of units of RBC transfused during the treatment period
    Time Frame
    during the treatment period
    Title
    Achieving a hemoglobin response by week 7
    Time Frame
    baseline to week 7
    Title
    Change in hemoglobin concentration from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Time to first hematopoietic response
    Time Frame
    throughout study
    Title
    Achieving a hemoglobin correction
    Time Frame
    throughout study
    Title
    Number and percentage of subjects who exceed the hemoglobin concentration threshold
    Time Frame
    throughout study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug Screening hemoglobin concentration less than or equal to 11.0 g/dL ECOG performance status of 0 to 2 (inclusive) Exclusion Criteria: History of seizure disorder Primary hematologic disorder that could cause anemia Unstable or uncontrolled disease/condition related to or affecting cardiac function Clinical evidence of chronic infection/inflammatory disease Positive test for HIV infection Previously confirmed neutralizing antibodies to rHuEPO Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20010101.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.aranesp.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Anemia in Patients With a Non-Myeloid Malignancy

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