NCT00271271已完成2 期
Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary 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
- 40
- 试验地点
- 1
- 主要终点
- Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
研究概览
简要总结
Primary:
·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer
Secondary:
·To evaluate the toxicity of the combination
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
- •Non-small cell bronchopulmonary cancer established by histological and/or cytological methods;
- •Advanced or metastatic disease (stage IIIB or IV);
- •At least one measurable lesion with one dimension (>= 20 mm by CT scan or >=10 mm by CT scan) outside of the irradiated area;
- •No prior chemotherapy;
- •Previous radiotherapy permitted as long as there has been a washout period of at least 4 weeks;
- •Age >= 18 years old;
- •ECOG Performance Status (PS): 0-1;
- •Life expectancy >3 months;
- •Hepatic and renal functions and blood count satisfactory:
- •Blood counts: white blood cells >= 3.0 x 10^9/l, neutrophils >= 1.5 x 10^9/l, platelets >= 150 x 10^9/l, haemoglobin >= 9 g/dl,
- •Hepatic function: bilirubin within the limit of the normal upper value, aspartate transaminases (AST) or alanine transaminases (ALT) <= 2.5 times the normal upper value
- •Renal function: creatinine clearance (calculated according to Cockroft and Gault) >= 40 ml/min;
- •Patients of reproductive age must use an effective contraceptive method;
- •Informed consent form signed before any procedure undertaken connected with the study
排除标准
- •Pregnant or breastfeeding patient;
- •Past record of other cancers (excluding basocellular or epidermoid cutaneous carcinoma or cured carcinoma of the cervix);
- •Symptomatic cerebral or leptomeningeal metastases;
- •Symptomatic peripheral neuropathy > 1 (NCI-CTC grade);
- •Presence of a serious disease or medical condition incompatible with the study (at the discretion of the investigator);
- •Treatment with another test product or participation in another therapeutic trial in the 4 weeks preceding inclusion in the study;
- •Concomitant treatment by any other anticancer therapy;
- •Concomitant treatment with phenytoin.
- •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
Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
次要结局
- Progression free survival (PFS), Overall survival (OS)
研究者
研究点 (1)
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