search
Back to results

Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies

Primary Purpose

Lymphoma, Breast Neoplasms, Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
darbepoetin alfa
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

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

Patients with non-myeloid malignancies * Patients receiving at least 12 weeks of chemotherapy on a 3-week cycle schedule * Patients with anemia (hgb >/= 9.0 and </= 11.0 g/dL)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 7, 2002
    Last Updated
    May 7, 2009
    Sponsor
    Amgen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00036023
    Brief Title
    Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies
    Official Title
    A Randomized, Open-Label, Dose-Timing Study of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection for Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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 chemotherapy every three weeks. 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
    Lymphoma, Breast Neoplasms, Lung Neoplasms, Multiple Myeloma, Chronic Lymphocytic Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    darbepoetin alfa

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patients with non-myeloid malignancies * Patients receiving at least 12 weeks of chemotherapy on a 3-week cycle schedule * Patients with anemia (hgb >/= 9.0 and </= 11.0 g/dL)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15911237
    Citation
    Glaspy J, Henry D, Patel R, Tchekmedyian S, Applebaum S, Berdeaux D, Lloyd R, Berg R, Austin M, Rossi G; Darbepoetin Alfa 20010162 Study Group. Effects of chemotherapy on endogenous erythropoietin levels and the pharmacokinetics and erythropoietic response of darbepoetin alfa: a randomised clinical trial of synchronous versus asynchronous dosing of darbepoetin alfa. Eur J Cancer. 2005 May;41(8):1140-9. doi: 10.1016/j.ejca.2005.01.021. Epub 2005 Apr 8.
    Results Reference
    result
    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_20010162.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

    Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies

    We'll reach out to this number within 24 hrs