Clinical trial · Interventional
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
NCT00305617CI-TRIAL-00004860completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antitumor drug screening assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.