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

May 13, 2011 updated by: The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael A. Vogelbaum, MD, PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE-CCF-6503
  • P30CA043703 (U.S. NIH Grant/Contract)
  • CASE-CCF-0967

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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