NCT00826852已完成2 期
Phase II Trial of Weekly Docetaxel and Four Weekly Carboplatin Combination in the First-line Treatment of Advanced Non-small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Efficacy by response rate
研究概览
简要总结
The purpose of this study is:
- to assess the efficacy of the combination in terms of Objective (clinical and radiological) Response Rate
- to assess the time to progression of the disease; assess the safety profile of the combination, and assess the survival time.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed inoperable locally advanced or metastatic non-small cell lung cancer
- •ECOG Performance Status is 0-2
- •At least one measurable lesion in two dimensions by means of CT scan
- •No brain metastases
- •No prior chemotherapy for this malignancy,
- •Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance measured in 24 hours urine ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 2.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
排除标准
- •Concomitant use of another anti-cancer therapy
- •Chemotherapy, radiotherapy or curative surgery
- •Evidence of intracerebral metastasis
- •Unstable medical condition that makes the patient to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural or peritoneal effusion; or presence of serious uncontrolled infection, diarrhea, ileus, interstitial pneumonia, pulmonary fibrosis.
- •Presence of other tumours different from basal cell carcinoma of the skin, with disease free survival less then 3 years.
- •Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
- •Social or psychological condition that render the patient inadequate for the follow-up of the study
- •Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Efficacy by response rate
时间窗: After the 3rd cycle, 6th cycle and at every follow up visit
次要结局
- Adverse events(At each visit)
- Efficacy by time to progression(Until the progression of all patients)
- Overall survival(At the end of the study)
研究者
研究点 (2)
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