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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
antitumor drug screening assay
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 21, 2006
Last Updated
May 13, 2011
Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00305617
Brief Title
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

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
antitumor drug screening assay
Primary Outcome Measure Information:
Title
CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Vogelbaum, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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