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Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ZD1839
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring NSCLC Lung Cancer, Non Small Cell 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: Biopsy proven non-small cell lung cancer Recurrent non-small cell lung cancer after previous surgery or radiation Advanced disease (stage IIIb or IV) No previous chemotherapy or biological therapy Require significant assistance with activities of daily living Measurable disease Adequate bone marrow, liver and kidney function Give written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Brain metastasis Meningeal metastasis Other uncontrolled malignancies Women pregnant or lactating No measurable disease outside previous radiation therapy field 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 response rate

    Secondary Outcome Measures

    Overall toxicity
    Quality of life

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    May 2, 2011
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193336
    Brief Title
    Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
    Official Title
    Phase II Trial of Single Agent ZD1839 (Iressa) in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    March 2004 (Actual)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    AstraZeneca

    4. Oversight

    5. Study Description

    Brief Summary
    Because of the demonstrated single agent activity and excellent tolerability in patients with refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment of patients with advanced non-small cell lung cancer who have poor performance status. In this phase II trial, we will investigate the single agent activity of first-line ZD1839 in patients with advanced non-small cell lung cancer with poor performance status
    Detailed Description
    Upon determination of eligibility, patients will be receive: ZD1839

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    NSCLC Lung Cancer, Non Small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ZD1839
    Primary Outcome Measure Information:
    Title
    Overall response rate
    Secondary Outcome Measure Information:
    Title
    Overall toxicity
    Title
    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: Biopsy proven non-small cell lung cancer Recurrent non-small cell lung cancer after previous surgery or radiation Advanced disease (stage IIIb or IV) No previous chemotherapy or biological therapy Require significant assistance with activities of daily living Measurable disease Adequate bone marrow, liver and kidney function Give written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Brain metastasis Meningeal metastasis Other uncontrolled malignancies Women pregnant or lactating No measurable disease outside previous radiation therapy field 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
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16179100
    Citation
    Spigel DR, Hainsworth JD, Burkett ER, Burris HA, Yardley DA, Thomas M, Jones SF, Dickson NR, Scullin DC, Bradof JE, Rubinsak JR, Brierre JE, Greco FA. Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a Minnie Pearl Cancer Research Network Phase II Trial. Clin Lung Cancer. 2005 Sep;7(2):127-32. doi: 10.3816/CLC.2005.n.028.
    Results Reference
    result
    Links:
    URL
    http://cigjournals.metapress.com/content/6822553744n47577/?p=0e5ad5d17e5c4241b3e7674ea8cf3df0&pi=7
    Description
    Published article in Clinical Lung Cancer

    Learn more about this trial

    Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

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