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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.
Sponsor:
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00305617
First received: March 21, 2006
Last updated: May 13, 2011
Last verified: July 2009
  Purpose

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 [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305617

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00305617     History of Changes
Other Study ID Numbers: CASE-CCF-6503, P30CA043703, CASE-CCF-6503, CASE-CCF-0967
Study First Received: March 21, 2006
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014