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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305617
• Other study ID #: CASE-CCF-6503
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: N/A
• First received: March 21, 2006
• Last updated: May 13, 2011
• Start date: January 2004

Study information

• Verified date: July 2009
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• antitumor drug screening assay

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment			No