NCT00252798已完成1 期
A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- To determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.
研究概览
简要总结
The primary objective of the trial is to determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.
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
- •Patients with histologically or cytologically confirmed locally advanced stage IIIA or IIIB NSCLC (without pleural effusion)
- •Patients with apical tumours and supraclavicular nodes are acceptable if both can be easily encompassed in one radiation field
- •Minimum life expectancy with treatment of 6 months
- •WHO performance status 0-1
排除标准
- •Patients with previous malignancies other than NSCLC
- •Previous radiotherapy for NSCLC
- •Previous immunotherapy or chemotherapy
- •Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •Forced expiratory volume in 1 second (FEV1) less than 1 litre (L)
- •Absolute neutrophil count (ANC) less than 1.5 x 109/L or platelets less than 100 x 109/L
- •Serum bilirubin greater than 1.25 times the upper limit of reference range
- •ALT or AST greater than 2.5 times the ULRR
结局指标
主要结局
To determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.
次要结局
- To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy
- Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)
- To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan
- To estimate the complete response rate (CR) as assessed by PET-FDG
- To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG
- To estimate overall survival
- To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation
- To determine the site of first failure (characterised as local-regional, distant or both)
研究者
研究点 (2)
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