Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer
NCT ID: NCT00390806
Last Updated: 2014-01-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
472 participants
INTERVENTIONAL
2006-12-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Topotecan to Treat Recurrent or Persistent Solid Tumors
NCT00382733
Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer
NCT00002537
Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors
NCT00193583
Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases
NCT02993146
The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)
NCT00043862
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
topotecan plus radiation
topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy.
HYCAMTIN, oral capsules
topotecan oral capsules 1.1 mg/m2
Radiation
Whole brain radiation
Whole brain radiation
Whole brain radiation 3 Gy/day for 10 days
Radiation
Whole brain radiation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HYCAMTIN, oral capsules
topotecan oral capsules 1.1 mg/m2
Radiation
Whole brain radiation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have received previous chemotherapy
* Must be 18 years of age of greater
* Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2
* At least 2 weeks must have elapsed since any surgery
* At least 4 weeks must have elapsed since any radiation to a non-CNS site
* Must have adequate bone marrow, renal, and live capacities
* Women must be of non-childbearing potential or practice adequate birth control
* Males must practice adequate methods of birth control
* Must sign written informed consent
Exclusion Criteria
* Prior treatment with topotecan
* Investigational agent within 30 days or 5 half-live
* Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib
* Primary or secondary immunodeficiencies
* Gastrointestinal conditions that affect GI absorption or motility
* Uncontrolled emesis
* Brain metastasis at time of initial diagnosis of NSCLC
* History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
* Pregnant or intending to become pregnant or intending to father a baby
* Any severe concurrent medical condition that could affect compliance.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Glendale, Arizona, United States
GSK Investigational Site
Hot Springs, Arkansas, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Duarte, California, United States
GSK Investigational Site
Pleasant Hill, California, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
Lakeland, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Elk Grove Village, Illinois, United States
GSK Investigational Site
Galesburg, Illinois, United States
GSK Investigational Site
Park Ridge, Illinois, United States
GSK Investigational Site
Rockford, Illinois, United States
GSK Investigational Site
Skokie, Illinois, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Westwood, Kansas, United States
GSK Investigational Site
Paducah, Kentucky, United States
GSK Investigational Site
Metairie, Louisiana, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Jackson, Mississippi, United States
GSK Investigational Site
Columbia, Missouri, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
Albany, New York, United States
GSK Investigational Site
Buffalo, New York, United States
GSK Investigational Site
Buffalo, New York, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Eugene, Oregon, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Bedford, Texas, United States
GSK Investigational Site
Corpus Christi, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Duncanville, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Lubbock, Texas, United States
GSK Investigational Site
Sherman, Texas, United States
GSK Investigational Site
Sugarland, Texas, United States
GSK Investigational Site
Everett, Washington, United States
GSK Investigational Site
Vancouver, Washington, United States
GSK Investigational Site
Madison, Wisconsin, United States
GSK Investigational Site
Moncton, New Brunswick, Canada
GSK Investigational Site
Hamilton, Ontario, Canada
GSK Investigational Site
Kingston, Ontario, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Greenfield Park, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Québec, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Csorna, , Hungary
GSK Investigational Site
Győr, , Hungary
GSK Investigational Site
Gyula, , Hungary
GSK Investigational Site
Mátraháza, , Hungary
GSK Investigational Site
Miskolc, , Hungary
GSK Investigational Site
Nyíregyháza, , Hungary
GSK Investigational Site
Pécs, , Hungary
GSK Investigational Site
Székesfehérvár, , Hungary
GSK Investigational Site
Szombathely, , Hungary
GSK Investigational Site
Törökbálint, , Hungary
GSK Investigational Site
Zalaegerszeg-Pozva, , Hungary
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Olsztyn, , Poland
GSK Investigational Site
Olsztyn, , Poland
GSK Investigational Site
Poznan, , Poland
GSK Investigational Site
Kazan', , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Obninsk, , Russia
GSK Investigational Site
Orenburg, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Voronezh, , Russia
GSK Investigational Site
Banská Bystrica, , Slovakia
GSK Investigational Site
Bratislava, , Slovakia
GSK Investigational Site
Nitra, , Slovakia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HYT105962
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.