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

May 30, 2017 updated by: GlaxoSmithKline

A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013 - 4496
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Bakersfield, California, United States, 93309
        • GSK Investigational Site
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • Los Angeles, California, United States, 90057
        • GSK Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0098
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • GSK Investigational Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • GSK Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • GSK Investigational Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • GSK Investigational Site
      • Minneapolis, Minnesota, United States, 55455
        • GSK Investigational Site
      • Robbinsdale, Minnesota, United States, 55422
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • Montana
      • St. Louis, Montana, United States, 63110
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43614-5809
        • GSK Investigational Site
    • Texas
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • GSK Investigational Site
      • La Crosse, Wisconsin, United States, 54601
        • GSK Investigational Site
      • Madison, Wisconsin, United States, 53792
        • GSK Investigational Site
      • Milwaukee, Wisconsin, United States, 53215
        • GSK Investigational Site
      • Wausau, Wisconsin, United States, 54401
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

August 14, 2002

First Submitted That Met QC Criteria

August 14, 2002

First Posted (Estimate)

August 15, 2002

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104864/535

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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