Last updated: 11/03/2018 01:15:12

The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)(SCLC)

GSK study ID
104864/535
See study documents
Clinicaltrials.gov ID
NCT00043862
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer with Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer
Trial description: This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: topotecan
    • Enrollment:
    60
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Lung Cancer, Small Cell
    Product
    topotecan
    Collaborators
    Not applicable
    Study date(s)
    August 2002 to November 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.
    • Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.
    • Extensive Stage SCLC.
    • Women who are pregnant or lactating.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.
    • Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.
    • Patients must give written informed consent to participate in the study.
    • Patients must be able to take oral medication.
    • Patients should be completely recovered from recent surgery.
    • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
    • Patients must be evaluated by the radiation oncologist prior to study entry.
    Exclusion criteria:
    • Extensive Stage SCLC.
    • Women who are pregnant or lactating.
    • Use of an investigational drug within 30 days prior to the first dose of study medication.
    • Any medically/clinically significant active infection.
    • Symptoms of the SCLC spreading to the brain.
    • Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy.
    • Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk.
    • Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53215
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New Orleans, Louisiana, United States, 70112
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Springfield, Massachusetts, United States, 01107
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    New Orleans, Louisiana, United States, 70121
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-01-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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    The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC), Trial ID 104864%2F535 | GSK