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Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Topotecan
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: Biopsy-proven small cell lung cancer, extensive stage disease Age > 65 years No previous chemotherapy or radiation therapy. Measurable or evaluable disease. Adequate bone marrow, liver and kidney function. Must be > 4 weeks from previous major surgery Must give written informed consent prior to study entry. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Meningeal involvement Serious active infections Serious underlying medical conditions Other active neoplasms 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

    Median survival
    1 year and 2 year survival
    Overall toxicity

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    July 27, 2010
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Institutional Review Board TriStar Nashville Market
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193401
    Brief Title
    Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer
    Official Title
    Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Institutional Review Board TriStar Nashville Market

    4. Oversight

    5. Study Description

    Brief Summary
    In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens
    Detailed Description
    Upon determination of eligibility, all patients will be receive: Topotecan

    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
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Topotecan
    Primary Outcome Measure Information:
    Title
    Overall response rate
    Secondary Outcome Measure Information:
    Title
    Median survival
    Title
    1 year and 2 year survival
    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: Biopsy-proven small cell lung cancer, extensive stage disease Age > 65 years No previous chemotherapy or radiation therapy. Measurable or evaluable disease. Adequate bone marrow, liver and kidney function. Must be > 4 weeks from previous major surgery Must give written informed consent prior to study entry. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Meningeal involvement Serious active infections Serious underlying medical conditions Other active neoplasms 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

    Learn more about this trial

    Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

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