Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305617
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2006-03-21
Brief Title:
Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE-CCF-0967 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CASE-CCF-6503 | None | None | None |