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)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70121
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
Status
Study Complete
Location
GSK Investigational Site
La Crosse, Wisconsin, United States, 54601
Status
Study Complete
Location
GSK Investigational Site
Scarborough, Maine, United States, 04074
Status
Study Complete
Location
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0098
Status
Study Complete
Location
GSK Investigational Site
Bakersfield, California, United States, 93309
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87109
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Montana, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Green Bay, Wisconsin, United States, 54301
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90057
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
Wausau, Wisconsin, United States, 54401
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45236
Status
Study Complete
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85013 - 4496
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
Status
Study Complete
Location
GSK Investigational Site
Duluth, Minnesota, United States, 55805
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32610
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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
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Access to clinical trial data by researchers
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