The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)
(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
1 other identifier
interventional
60
1 country
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 14, 2002
CompletedFirst Posted
Study publicly available on registry
August 15, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedMay 31, 2017
March 1, 2013
3.3 years
August 14, 2002
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate
Secondary Outcomes (1)
Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (31)
GSK Investigational Site
Phoenix, Arizona, 85013 - 4496, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Bakersfield, California, 93309, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Los Angeles, California, 90057, United States
GSK Investigational Site
Gainesville, Florida, 32610, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
Lexington, Kentucky, 40536-0098, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
New Orleans, Louisiana, 70121, United States
GSK Investigational Site
Shreveport, Louisiana, 71103, United States
GSK Investigational Site
Scarborough, Maine, 04074, United States
GSK Investigational Site
Springfield, Massachusetts, 01107, United States
GSK Investigational Site
Duluth, Minnesota, 55805, United States
GSK Investigational Site
Minneapolis, Minnesota, 55455, United States
GSK Investigational Site
Robbinsdale, Minnesota, 55422, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Saint Louis, Montana, 63110, United States
GSK Investigational Site
Albuquerque, New Mexico, 87109, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Akron, Ohio, 44304, United States
GSK Investigational Site
Cincinnati, Ohio, 45236, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Toledo, Ohio, 43614-5809, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Green Bay, Wisconsin, 54301, United States
GSK Investigational Site
La Crosse, Wisconsin, 54601, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53215, United States
GSK Investigational Site
Wausau, Wisconsin, 54401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2002
First Posted
August 15, 2002
Study Start
August 1, 2002
Primary Completion
November 1, 2005
Last Updated
May 31, 2017
Record last verified: 2013-03