NCT00305617已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Diagnostic
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Depakote, Depakene
- •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
排除标准
- 未提供
结局指标
主要结局
CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular DrainageSubarachnoid Hemorrhage, AneurysmalNCT06119061Aaron Cook20
已完成
2 期
BATTLE Program: Erlotinib in Previously Treated Subjects With Advanced NSCLCLung CancerNCT00410059M.D. Anderson Cancer Center59
已完成
2 期
BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)Lung CancerNCT00411632M.D. Anderson Cancer Center37
进行中（未招募）
不适用
Pharmacodynamic study of Erlotinib (Tarceva) in patients with mestastatic or locally advanced Epidermoid carcinoma of the head and neckMestastatic or locally advanced Epidermoid carcinoma of the head and neckEUCTR2005-003814-14-ESnidad Integral de Investigación en Oncología, S.L.49
已完成
不适用
Cerebrospinal Fluid (CSF) Raltegravir SubstudyHIV InfectionsNCT00718029University of California, San Diego4