NCT00034697终止2 期
A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
研究概览
简要总结
Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Histologic confirmation of non-small-cell lung cancer
- •Stable systemic disease
- •Maximum of one prior chemotherapy regimen for metastatic systemic disease
- •Radiotherapy for local control or palliative bony lesions is allowed
- •Karnofsky of greater than or equal to 70%
- •Adequate hematologic, renal and liver function
排除标准
- •Patients eligible for surgery of the brain
- •Any previous chemotherapy for the brain metastasis
- •Chemotherapy within 4 weeks or previous temozolomide
- •Prior radiotherapy to the brain
- •Radiation therapy to greater than 50% of the bone marrow
- •Insufficient recovery from previous therapies
- •Active nonmalignant systemic disease
- •Inability to take oral medication
- •Pregnant or nursing women
- •Non use of adequate contraceptive techniques, negative urine pregnancy test is required
- •Known AIDS related illness
研究者
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