Cerebrospinal Fluid Levels of Erlotinib in Patients Recei... | NCT00305617

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

NCT00305617

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

May 17, 2011Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

antitumor drug screening assay

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Dec 2007Actual

Completion Date

Not provided

First Submitted Date

Mar 21, 2006

First Submission Date that Met QC Criteria

Mar 21, 2006

First Posted Date

Mar 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2011

Last Update Posted Date

May 17, 2011Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Name	Type	Description	Arm Group Labels	Other Names
antitumor drug screening assay	Other

Measure	Description	Time Frame
CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Type	Link
P30CA043703	U.S. NIH Grant/Contract	View source
CASE-CCF-6503
CASE-CCF-0967

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis