Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00305617|
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : May 17, 2011
RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in planning treatment for some types of cancer.
PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Other: antitumor drug screening assay||Not Applicable|
- Determine the cerebrospinal fluid penetration of erlotinib in a subset of patients who are undergoing treatment with erlotinib for stage III non-small cell lung cancer and have no CNS metastatic disease.
OUTLINE: This is a pilot, nonrandomized study.
Patients will undergo single lumbar puncture (LP) to remove cerebrospinal fluid for analysis.
After completion of study, patients will be monitored for 1 month after LP to assess for any LP-related complications.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Official Title:||Evaluation of CSF Levels of Tarceva (OSI-774) in Patients With Stage III Non-Small Cell Lung Cancer and No CNS Involvement Undergoing Treatment With Tarceva|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2007|
- CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305617
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Michael A. Vogelbaum, MD, PhD||The Cleveland Clinic|