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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00305617
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : May 17, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Lung Cancer Other: antitumor drug screening assay

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : January 2004
Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305617


Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
More Information

ClinicalTrials.gov Identifier: NCT00305617     History of Changes
Other Study ID Numbers: CASE-CCF-6503
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-CCF-0967
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: July 2009

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents