NCT00385398撤回2 期
Phase II Quality of Life Study of Stereotactic RadioSurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Cognitive function
研究概览
简要总结
RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment.
PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.
详细描述
OBJECTIVES:
Primary
- Determine the effect of stereotactic radiosurgery, temozolomide, and erlotinib hydrochloride on cognitive function in patients with non-small cell lung cancer and brain metastases.
Secondary
- Determine the feasibility and safety of this regimen, in terms of tumor response, time to tumor progression in brain, survival, physical functioning, and quality of life, in these patients.
- Determine the frequency of O6-methylguanine-DNA methyltransferase promoter methylation in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer meeting the following criteria:
- •One to 3 brain metastases, meeting the following criteria:
- •No larger than 3 cm
- •Greater than 5 mm from the optic apparatus
- •Not involving the brainstem, pons, medulla, or midbrain
- •Stable systemic disease for the past 3 months
- •Less than 3 months since completion of primary treatment
- •Measurable CNS disease as defined by RECIST criteria
- •No leptomeningeal disease documented by MRI or cerebrospinal fluid cytologic evaluation
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 12 weeks
- •Karnofsky performance status 60-100%
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 3.0 times ULN
- •Serum creatinine ≤ 1.5 mg/dL
- •Creatinine clearance > 50 mL/min
- •No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No concurrent major medical illness or psychiatric impairment that, in the investigator's opinion, would preclude study participation
- •No concurrent active infections
- •No known HIV positivity
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior complete resection of all brain metastases
- •No prior brain radiation therapy
- •No prior temozolomide or erlotinib hydrochloride
- •No concurrent enzyme-inducing anti-epileptic drugs
- •No concurrent recombinant interleukin-11
- •No other concurrent anticancer investigational or commercial agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery
- •No concurrent enrollment on another clinical trial
- •Surgery for symptomatic brain lesions prior to radiosurgery allowed
排除标准
- 未提供
结局指标
主要结局
Cognitive function
时间窗: 2 years
次要结局
- Tumor response(2 years)
- Time to tumor progression in brain(2 years)
- Survival(2 years)
- Quality of life as measured by FACT subscale(2 years)
- Physical functioning as measured by Karnofsky performance status and Katz index of activities of daily living(2 years)
- Frequency of O6-methylguanine-DNA methyltransferase promoter methylation(2 years)
研究者
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