Clinical trial NCT00305617: Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-03-22
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael A. Vogelbaum, MD, PhD
role: STUDY_CHAIR
References: