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

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