Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: antitumor drug screening assay


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Patients must be enrolled in the trial: A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer, Principal Investigator: T. Mekhail, M.D. Patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week No known CNS primary or metastatic cancer at any time prior to time of enrollment No MRI evidence of pathological enhancement at the time of study entry PATIENT CHARACTERISTICS: Patients must use adequate birth control measures while in the study No significant side effects to erlotinib that require dose reduction or interruption None of the following medical issues which could make a lumbar puncture unsafe: Platelets < 100,000/mm³ INR > 1.1 Known bleeding dyscrasia Absolute neutrophil count < 1,500/mm³ Ongoing systemic bacterial infection PRIOR CONCURRENT THERAPY: Patients on modest or anti-epileptic therapy must be on nonenzyme-inducing drug only, including any of the following: Neurontin Lamictal Depakote, Depakene Felbatol Keppra Gabitril Topimax Zonegran No concurrent enzyme-inducing anti-epileptic drugs such as phenytoin, carbamazepine, or phenobarbital No concurrent other drug known to affect the metabolism of erlotinib No concurrent anticoagulant therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: antitumor drug screening assay|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer