Status:
COMPLETED
Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
Phase:
NA
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 ab...
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 m...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00305617
Start Date
January 1 2004
Last Update
May 17 2011
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195