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Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sagopilone (BAY86-5302, ZK 219477)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma focused on measuring Sagopilone, Epothilone, SCLC, Small Cell Lung Cancer, Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Histologically or cytologically proven Small-cell lung cancer (SCLC) Stage of extensive disease defined by the presence of distant metastases At least 1 unidimensionally measureable lesion WHO performance status 0 to 1 No previous SCLC-related chemotherapy No previous SCLC-related surgery No previous radiotherapy (excepting for brain metastasis) Adequate function of major organs and systems Nervous system No Grade 2 or greater peripheral neuropathy Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No arrythmia needing continuous treatment No other uncontrolled concurrent illness Exclusion Criteria: Superior vena cava syndrome or obstruction of any vital structure Untreated malignant hypercalcemia Pleural effusion as the only manifestation of disease Extensive disease amenable to radiation therapy Symptomatic brain metastases requiring whole brain irradiation Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Sagopilone

    Arm Description

    Outcomes

    Primary Outcome Measures

    Response to treatment according to the modRECIST (complete response or partial response)

    Secondary Outcome Measures

    Duration of complete or partial tumor response
    Time to tumor progression
    Number of participants with adverse events

    Full Information

    First Posted
    March 3, 2006
    Last Updated
    December 30, 2015
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00299390
    Brief Title
    Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer
    Official Title
    Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    April 2007 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bayer

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer
    Detailed Description
    The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Cell Lung Carcinoma
    Keywords
    Sagopilone, Epothilone, SCLC, Small Cell Lung Cancer, Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sagopilone
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Sagopilone (BAY86-5302, ZK 219477)
    Intervention Description
    Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion
    Primary Outcome Measure Information:
    Title
    Response to treatment according to the modRECIST (complete response or partial response)
    Time Frame
    Every 2 cycles until tumor progression i.e. approximately every 6 weeks
    Secondary Outcome Measure Information:
    Title
    Duration of complete or partial tumor response
    Time Frame
    Every 2 cycles until tumor progression i.e. approximately every 6 weeks
    Title
    Time to tumor progression
    Time Frame
    Every 2 cycles until tumor progression i.e. approximately every 6 weeks
    Title
    Number of participants with adverse events
    Time Frame
    Approximately 30 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically or cytologically proven Small-cell lung cancer (SCLC) Stage of extensive disease defined by the presence of distant metastases At least 1 unidimensionally measureable lesion WHO performance status 0 to 1 No previous SCLC-related chemotherapy No previous SCLC-related surgery No previous radiotherapy (excepting for brain metastasis) Adequate function of major organs and systems Nervous system No Grade 2 or greater peripheral neuropathy Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No arrythmia needing continuous treatment No other uncontrolled concurrent illness Exclusion Criteria: Superior vena cava syndrome or obstruction of any vital structure Untreated malignant hypercalcemia Pleural effusion as the only manifestation of disease Extensive disease amenable to radiation therapy Symptomatic brain metastases requiring whole brain irradiation Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.clinicaltrialsregister.eu/
    Description
    Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

    Learn more about this trial

    Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

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