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The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)
This study has been completed.
Study NCT00043862   Information provided by GlaxoSmithKline
First Received: August 14, 2002   Last Updated: May 15, 2009   History of Changes

August 14, 2002
May 15, 2009
August 2002
 
Response rate
Same as current
Complete list of historical versions of study NCT00043862 on ClinicalTrials.gov Archive Site
Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability
Same as current
 
The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)
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.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Small Cell Lung Cancer
Drug: topotecan
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043862
Study Director, GSK
104864/535
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP