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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00305617
Enrollment
10
Registered
2006-03-22
Start date
2004-01-31
Completion date
Unknown
Last updated
2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026