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Tracking Information | |||||||||||||
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First Received Date † | September 27, 2007 | ||||||||||||
Last Updated Date | May 27, 2008 | ||||||||||||
Start Date † | May 2006 | ||||||||||||
Current Primary Outcome Measures † |
To establish the safety of concurrent palliative whole brain radiotherapy and two doses of erlotinib in patients with brain metastases from NSCLC [ Time Frame: Until death ] [ Designated as safety issue: Yes ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00536861 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † | |||||||||||||
Original Secondary Outcome Measures † | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Safety Study of Radiotherapy and Concurrent Erlotinib (Tarceva®) for Brain Metastases From a Non-Small Cell Lung Cancer | ||||||||||||
Official Title † | A Phase I Study of Radiotherapy Concurrent With Erlotinib (Tarceva®) in the Treatment of Brain Metastases From Non-Small Cell Lung Cancer (NSCLC) | ||||||||||||
Brief Summary | Lung cancer is a leading cause of death worldwide. Brain metastases manifest as the first site of disease failure in between 15-30% of patients with non-small cell lung cancer (NSCLC). The standard treatment for patients with multiple brain metastases is whole brain radiotherapy but this results in only a modest survival of 3-6 months. Drugs that can enhance the effect of cranial irradiation (radiosensitizers) may improve the the response rates. Erlotinib (Tarceva) is an oral agent that has been registered for treatment in patients with metastatic NSCLC. Erlotinib has shown tumor activity in patients presenting with brain metastases, and preclinical studies show that it may be a radiosensitizer. As a prelude to studies investigating the combination of Erlotinib and cranial radiotherapy, the present study will be performed to evaluate the safety of combining both these treatments. |
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Detailed Description | |||||||||||||
Study Phase | Phase I | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||||||
Condition † |
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Intervention † | Drug: erlotinib | ||||||||||||
Study Arms / Comparison Groups | |||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Completed | ||||||||||||
Enrollment † | 11 | ||||||||||||
Completion Date | December 2007 | ||||||||||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | Netherlands | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00536861 | ||||||||||||
Responsible Party | Professor S Senan, VU Medical Center | ||||||||||||
Secondary IDs †† | |||||||||||||
Study Sponsor † | VU University Medical Center | ||||||||||||
Collaborators †† | |||||||||||||
Investigators † |
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Information Provided By | VU University Medical Center | ||||||||||||
Verification Date | April 2008 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |