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

NeuroTherapia, Inc.

Status: Completed

Conditions: Lung Cancer

Treatments: Other: antitumor drug screening assay

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00305617

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CCF-0967

CASE-CCF-6503

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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