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A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer

Primary Purpose

Neutropenia, Breast Cancer, Lung Cancer

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Neulasta (pegfilgrastim)
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neutropenia

Eligibility Criteria

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

Inclusion Criteria: >/= 65 years old documented diagnosis of lung, breast, or ovarian cancer, or NHL scheduled to receive one of 15 standard chemotherapy regimens chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease life expectancy of at least 3 months ECOG performance status </=2 adequate renal and hematologic function informed consent for participation in the study prior to any study specific procedures Exclusion Criteria: known hypersensitivity to any of the products to be administered during dosing primary prophylactic antibiotics in all cycles prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation clinically symptomatic brain metastases Folstein mini-mental state exam score <18 Any premalignant myeloid condition or any malignancy with myeloid characteristics History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies unstable/uncontrolled cardiac conditions or hypertension active infection subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment Group 1 (Primary Prophylaxis)

    Treatment Group 2 (Secondary Prophylaxis)

    Arm Description

    Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1

    Per Investigator's discretion

    Outcomes

    Primary Outcome Measures

    Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day

    Secondary Outcome Measures

    Incidence of grade 3 and 4 neutropenia
    Dose delays or dose reductions
    Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day

    Full Information

    First Posted
    January 12, 2006
    Last Updated
    October 7, 2010
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00277160
    Brief Title
    A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
    Official Title
    A Randomized, Open Label, Multicenter Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis as an Adjunct to Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    January 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neutropenia, Breast Cancer, Lung Cancer, Non-Hodgkin's Lymphoma, Ovarian Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    852 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group 1 (Primary Prophylaxis)
    Arm Type
    Experimental
    Arm Description
    Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1
    Arm Title
    Treatment Group 2 (Secondary Prophylaxis)
    Arm Type
    Active Comparator
    Arm Description
    Per Investigator's discretion
    Intervention Type
    Drug
    Intervention Name(s)
    Neulasta (pegfilgrastim)
    Intervention Description
    Commercial pegfilgrastim 6mg single subcutaneous fixed-dose
    Primary Outcome Measure Information:
    Title
    Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day
    Time Frame
    End of the last cycle of chemotherapy or the date of early termination from the study
    Secondary Outcome Measure Information:
    Title
    Incidence of grade 3 and 4 neutropenia
    Time Frame
    End of the last cycle of chemotherapy or the date of early termination from the study
    Title
    Dose delays or dose reductions
    Time Frame
    End of the last cycle of chemotherapy or the date of early termination from the study
    Title
    Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day
    Time Frame
    End of the last cycle of chemotherapy or the date of early termination from the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >/= 65 years old documented diagnosis of lung, breast, or ovarian cancer, or NHL scheduled to receive one of 15 standard chemotherapy regimens chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease life expectancy of at least 3 months ECOG performance status </=2 adequate renal and hematologic function informed consent for participation in the study prior to any study specific procedures Exclusion Criteria: known hypersensitivity to any of the products to be administered during dosing primary prophylactic antibiotics in all cycles prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation clinically symptomatic brain metastases Folstein mini-mental state exam score <18 Any premalignant myeloid condition or any malignancy with myeloid characteristics History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies unstable/uncontrolled cardiac conditions or hypertension active infection subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents
    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
    18165618
    Citation
    Balducci L, Al-Halawani H, Charu V, Tam J, Shahin S, Dreiling L, Ershler WB. Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist. 2007 Dec;12(12):1416-24. doi: 10.1634/theoncologist.12-12-1416.
    Results Reference
    result
    PubMed Identifier
    20118030
    Citation
    Flores IQ, Ershler W. Managing neutropenia in older patients with cancer receiving chemotherapy in a community setting. Clin J Oncol Nurs. 2010 Feb;14(1):81-6. doi: 10.1188/10.CJON.81-86.
    Results Reference
    result
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    A Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis After Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer

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