Cetuximab (C225) and Radiation in Elderly and /or Poor Performance Status Patients With Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study to Evaluate Survival and Toxicity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 175
- 主要终点
- 11-month Survival Rate
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
* Determine the 11 month survival rate in older and/or poor performance status patients with stage IIIA or stage IIIB non-small cell lung cancer treated with cetuximab and radiotherapy.
Secondary
- Determine the tumor response rate, overall survival, and time to disease progression in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine whether fear of death is less severe in the oldest of patients treated with this regimen.
- Determine whether fear of death predicts survival of patients treated with this regimen.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- •Stage IIIA or IIIB disease
- •Must be a candidate for curative radiotherapy
- •Not a candidate for other concurrent chemotherapy and radiotherapy
- •No surgical treatment available
- •No pleural effusion suspected or proven to be malignant
- •No stage IV disease by bone scan or positron emission tomography scan, CT scan or MRI of the brain, and CT scan of the chest within the past 30 days
- •PATIENT CHARACTERISTICS:
- •Age * 18 and over
- •Performance status
- •Eastern Cooperative Oncology Group (ECOG) 0-2 (age ≥ 65 years)
- •ECOG 2 (age 18 to 64 years)
- •Life expectancy
- •* At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST ≤ 3 times ULN
- •Creatinine ≤ 1.5 times ULN
- •FEV_1 ≥ 1 L
- •No idiopathic pulmonary fibrosis
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Magnesium normal
- •No uncontrolled infection
- •No other severe underlying disease that would preclude study entry
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
- •No major psychiatric illness that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •* Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No prior chemotherapy for NSCLC
- •Endocrine therapy
- •* Not specified
- •Radiotherapy
- •No prior therapeutic radiotherapy to the chest
- •No concurrent intensity modulated radiotherapy
- •* No prior epidermal growth factor receptor inhibitors
排除标准
- 未提供
研究组 & 干预措施
cetuximab/Radiation
Cetuximab (C225) and Radiation
干预措施: radiation therapy (Radiation)
cetuximab/Radiation
Cetuximab (C225) and Radiation
干预措施: cetuximab (Biological)
结局指标
主要结局
11-month Survival Rate
时间窗: From baseline to 11 months.
Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with "success", unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.
次要结局
- Time to Disease Progression(From Baseline to up to 3 years)
- Tumor Response (Complete and Partial)(Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration)
- Survival Time(From baseline to up to 3 years)