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Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Imatinib
Irinotecan
Carboplatin
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: Small cell lung cancer with extensive stage disease confirmed by biopsy Measurable or evaluable disease Ability to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney No active brain metastasis. No previous chemotherapy or radiation therapy Give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Limited stage disease (includes IA, IB, IIA, IIB, and IIIA) Active brain metastasis Age < 18 years old History of a prior malignancy within three years Women pregnant or lactating. 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
    Response duration

    Secondary Outcome Measures

    Time to progression
    Overall toxicity

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    June 24, 2010
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Novartis, Pharmacia and Upjohn
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193349
    Brief Title
    Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
    Official Title
    Phase II Evaluation of Gleevec Combined With Camptosar Plus Paraplatin in Patients With Previously Untreated Extensive Stage SCLC
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Novartis, Pharmacia and Upjohn

    4. Oversight

    5. Study Description

    Brief Summary
    This study will evaluate combination chemotherapy for patients with extensive stage small cell lung cancer combined with the potentially useful growth inhibiting effects of Gleevec.
    Detailed Description
    Upon determination of eligibility, all patients will be receive: Irinotecan + Carboplatin + Imatinib

    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 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)
    Imatinib
    Intervention Type
    Drug
    Intervention Name(s)
    Irinotecan
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Primary Outcome Measure Information:
    Title
    Overall response rate
    Title
    Response duration
    Secondary Outcome Measure Information:
    Title
    Time to progression
    Title
    Overall toxicity

    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: Small cell lung cancer with extensive stage disease confirmed by biopsy Measurable or evaluable disease Ability to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney No active brain metastasis. No previous chemotherapy or radiation therapy Give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Limited stage disease (includes IA, IB, IIA, IIB, and IIIA) Active brain metastasis Age < 18 years old History of a prior malignancy within three years Women pregnant or lactating. 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
    17805064
    Citation
    Spigel DR, Hainsworth JD, Simons L, Meng C, Burris HA 3rd, Yardley DA, Grapski R, Schreeder M, Mallidi PV, Greco FA; Minnie Pearl Cancer Research Network. Irinotecan, carboplatin, and imatinib in untreated extensive-stage small-cell lung cancer: a phase II trial of the Minnie Pearl Cancer Research Network. J Thorac Oncol. 2007 Sep;2(9):854-61. doi: 10.1097/JTO.0b013e31814617b7.
    Results Reference
    result
    Links:
    URL
    http://journals.lww.com/jto/pages/articleviewer.aspx?year=2007&issue=09000&article=00013&type=abstract
    Description
    Published article in the Journal of Thoracic Oncology

    Learn more about this trial

    Gleevec Combined With Camptosar Plus Paraplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer

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