Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 42
- 主要终点
- Progression free survival at 15 weeks.
研究概览
简要总结
This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.
The anticipated time on study treatment is until disease progression. Target sample size is 156.
The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .
详细描述
In this study, the patient will be randomized in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.
Assessment during treatment: Physical examination, ECG,: every 3 weeks, laboratory tests: weekly, every 3 weeks pulmonary X-ray .The CT scans:. Measurable targets are assessed by RECIST compared to the beginning of treatment: at 6 weeks (day 42 EVA 2), 12 weeks (D84 EVA 3), 15 weeks (D105 EVA 4: Evaluation of the SSP) and then every 6 weeks until progression.
Quality of life will be assessed Day 42 then every 6 weeks during chemotherapy, Tolerability will be assessed at each visit based on CTC v4.0 criteria.
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
- 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
- •Histologically proven NSCLC (
- •Mutational status of EGFR : wild type or unknown
- •Stage IV disease with cytologic or histologic documentation in patients with a single easily accessible metastasis or metastatic relapses in a non irradiated region from a primary tumor treated with surgery or radiotherapy (with cytologic or histologic documentation of relapse)
- •Presence of at least one measurable target lesion (one dimension) in a non irradiated region (at least 10 mm on spiral computed tomography).
- •Age ≥ 18 years
- •Performance status 0,1,2 exception : age > 74 years only PS 0 or 1
- •Normal hepatic function
- •Normal renal function
- •Normal calcemia
- •Normal haematological function
- •Life expectancy > 12 weeks.
- •Women of child bearing potential must use effective contraception.
- •Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
- •Written informed consent to participate in the study.
排除标准
- •PS > 2, exception : age > 74 years only PS ≥ 2
- •Presence of another cancer
- •Previous treatment with an anti egfr agent or docetaxel
- •QT prolongation (>470 ms)
- •Uncontrolled arterial hypertension.
- •Concurrent radiotherapy, except for palliative bone irradiation.
- •Stroke less than 6 months before study entry.
- •Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial
- •Uncontrolled infection.
- •Caval syndrome
- •Other organic disorders preventing inclusion in the trial
- •Malabsorption syndrome
- •Allergy to erlotinib or one of its constituents
- •Allergy to docetaxel or one of its constituents
- •Pregnancy and breast-feeding
- •Surgery less than two months before study entry
研究组 & 干预措施
Erlotinib
干预措施: Erlotinib + docetaxel (Drug)
Docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression free survival at 15 weeks.
时间窗: at 15 weeks
Progression Free Survival at 15 Weeks.
时间窗: at 15 weeks
次要结局
- Toxicities and feasibility(15 Weeks)
- Free survival at 12 months(12 months)
- Survival Rate at 12 Months(12 months)
- Overall Survival(12 mois)
- Progression-free Survival(12 months)