A Phase II Study of Treatment of Brain Metastases From Non-Small Cell Lung Cancer With Concurrent Whole Brain Radiation Therapy and Pemetrexed
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Response of Intracranial Metastases (Complete and Partial Response)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving whole-brain radiation therapy together with pemetrexed works in treating patients with brain metastases from non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Estimate the response in patients with intracranial brain metastases from non-small cell lung cancer treated with whole-brain radiotherapy and pemetrexed disodium.
Secondary
- Determine the toxicity of this regimen in these patients.
- Estimate the overall survival of patients treated with this regimen.
- Evaluate the functional status of patients treated with this regimen.
- Assess neurological function and progression in patients treated with this regimen.
- Determine the response of patients with extracranial disease treated with pemetrexed disodium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Karnofsky performance status 70-100% OR ≥ 70 years of age
- •Life expectancy > 3 months
- •Absolute neutrophil count (ANC) > 1,500/mm³
- •Platelet count > 100,000/mm³
- •Hemoglobin ≥ 8 g/dL
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine clearance ≥ 45 mL/min
- •Able to take vitamins, folic acid, and corticosteroids
排除标准
- •Contraindication or intolerance to corticosteroid therapy
- •Other malignancies within the past 5 years and disease-free OR prognosis is best defined by the NSCLC in the opinion of the attending physician
- •Pregnant or nursing
- •Positive pregnancy test
- •Fertile patients must use effective contraception
- •HIV positive
- •Severe hypersensitivity to pemetrexed disodium
- •Unable to discontinue NSAIDs for ≥ 5 days
- •History of underlying dementia, Parkinson's disease, or Alzheimer's disease
研究组 & 干预措施
Single Arm Study
Single Arm Study
干预措施: pemetrexed disodium (Drug)
Single Arm Study
Single Arm Study
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Response of Intracranial Metastases (Complete and Partial Response)
时间窗: 126 days
Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Number of Subjects Experiencing Adverse Events(maximum 5 months)
- Estimate the Overall Survival of Patients Treated With This Regimen.(4 years)
- Evaluate the Functional Status of Patients Treated With This Regimen.(baseline functional status only)
- Neurological Function by Radiation Oncology Group (RTOG) Neurological Function Classification(At Baseline, 30 days, and at end of treatment (maximum 5 months).)
- Neurological Function by Mini Mental State Examination(Baseline (pre-treatment), 30 days (Cycle 2 Day 1), and maximum 5 months (end of treatment).)
- Response of Patients With Extracranial Disease Treated With Pemetrexed(maximum 5 months)