A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause
研究概览
简要总结
The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.
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
- •Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas.
- •Patient must be previously treated with a systemic gemcitabine based regimen
- •Adequate bone marrow, kidney and liver functions
排除标准
- •ECOG performance status (PS) of 2-3-
- •Prior locoregional radiotherapy for pancreatic cancer.
- •Symptomatic brain metastases or leptomeningeal disease.
- •Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases.
- •Other concurrent malignancy
- •Other protocol-defined exclusion/inclusion criteria may apply
研究组 & 干预措施
Larotaxel (XRP9881)
干预措施: Larotaxel (XRP9881) (Drug)
5-Fluorouracil or capecitabine
Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.
干预措施: 5-Fluorouracil (Drug)
5-Fluorouracil or capecitabine
Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.
干预措施: Capecitabine (Drug)
结局指标
主要结局
overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause
时间窗: study period
次要结局
- Progression free survival (PFS); Overall Response Rate (proportion of patients with confirmed RECIST-defined complete response (CR) or partial response (PR); clinical benefit based on the measurement of tumor related symptoms;(study period)