跳至主要内容
临床试验/NCT00625664
NCT00625664已完成3 期

Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

Sanofi160 个研究点 分布在 1 个国家目标入组 337 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Sanofi
入组人数
337
试验地点
160
主要终点
Overall survival 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

This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.

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

入选标准

  • Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer
  • ECOG Performance Status 0 or 1
  • No prior palliative chemotherapy

排除标准

  • (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse
  • Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization
  • Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m²
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

研究组 & 干预措施

1

Experimental

干预措施: larotaxel (XRP9881) (Drug)

1

Experimental

干预措施: cisplatin (Drug)

2

Active Comparator

干预措施: gemcitabine (Drug)

2

Active Comparator

干预措施: cisplatin (Drug)

结局指标

主要结局

Overall survival 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

  • Radiological tumor assessments (CT/MRI)(at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression)
  • Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status(at screening and every cycle)

研究者

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (160)

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Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin... | 临床试验