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

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.

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