Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer
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.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Diagnostic
|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|
- CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305617
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Michael A. Vogelbaum, MD, PhD||The Cleveland Clinic|