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Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Gemcitabine
Vinorelbine
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: To be included in this study, you must meet the following criteria: Non-small cell bronchogenic carcinoma Newly diagnosed unresectable stage IIIB or stage IV disease Patients with stage IIIB disease should be ineligible for combined therapy Patients must have measurable lesion definable by X-ray or CT scan. No prior antineoplastic chemotherapy for lung cancer prior to study entry Age > 18 years Able to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney function Written informed consent must be obtained prior to study entry Patients must be available for treatment and followup. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Female patient pregnant or lactating History of heart disease Serious active infection at the time of treatment Other serious underlying medical condition Brain metastasis Patients without measurable disease Uncontrolled diabetes mellitus defined as random blood sugar > 250mg/dL Dementia or significantly altered mental status Significant peripheral neuropathy by history or physical examination. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Overall survival.

    Secondary Outcome Measures

    Overall toxicity
    Overall response rate
    Time-to-progression
    Assess the quality of life

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    July 27, 2010
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Eli Lilly and Company, GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193362
    Brief Title
    Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer
    Official Title
    Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Eli Lilly and Company, GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer
    Detailed Description
    Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: Paclitaxel + Carboplatin + Gemcitabine Gemcitabine + Vinorelbine For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Type
    Drug
    Intervention Name(s)
    Vinorelbine
    Primary Outcome Measure Information:
    Title
    Overall survival.
    Secondary Outcome Measure Information:
    Title
    Overall toxicity
    Title
    Overall response rate
    Title
    Time-to-progression
    Title
    Assess the quality of life

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included in this study, you must meet the following criteria: Non-small cell bronchogenic carcinoma Newly diagnosed unresectable stage IIIB or stage IV disease Patients with stage IIIB disease should be ineligible for combined therapy Patients must have measurable lesion definable by X-ray or CT scan. No prior antineoplastic chemotherapy for lung cancer prior to study entry Age > 18 years Able to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney function Written informed consent must be obtained prior to study entry Patients must be available for treatment and followup. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Female patient pregnant or lactating History of heart disease Serious active infection at the time of treatment Other serious underlying medical condition Brain metastasis Patients without measurable disease Uncontrolled diabetes mellitus defined as random blood sugar > 250mg/dL Dementia or significantly altered mental status Significant peripheral neuropathy by history or physical examination. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony Greco, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17922972
    Citation
    Greco FA, Spigel DR, Kuzur ME, Shipley D, Gray JR, Thompson DS, Burris HA, Yardley DA, Pati A, Webb CD, Gandhi JG, Hainsworth JD. Paclitaxel/Carboplatin/gemcitabine versus gemcitabine/vinorelbine in advanced non-small-cell lung cancer: a phase II/III study of the Minnie Pearl Cancer Research Network. Clin Lung Cancer. 2007 Sep;8(8):483-7. doi: 10.3816/CLC.2007.n.032.
    Results Reference
    result
    Links:
    URL
    http://cigjournals.metapress.com/content/j662866rh7152581/?p=38ed22b862d2470fb98c82b3d3c7dc94&pi=3
    Description
    Published article in Clinical Lung Cancer

    Learn more about this trial

    Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer

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