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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
The Cleveland Clinic Identifier:
First received: March 21, 2006
Last updated: May 13, 2011
Last verified: July 2009

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.

Condition Intervention
Lung Cancer Other: antitumor drug screening assay

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment

Estimated Enrollment: 10
Study Start Date: January 2004
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00305617

United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
  More Information Identifier: NCT00305617     History of Changes
Other Study ID Numbers: CASE-CCF-6503
P30CA043703 ( U.S. NIH Grant/Contract )
Study First Received: March 21, 2006
Last Updated: May 13, 2011

Keywords provided by The Cleveland Clinic:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents processed this record on August 16, 2017