EUCTR2007-001943-23-IT进行中（未招募）不适用
Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer - CILAB
Sanofi-Aventis Recherche et De'veloppement0 个研究点目标入组 900 人开始时间: 2008年2月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 Performans Status < ou = 2. - No prior palliative chemotherapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age < 18 years old. - Disease localized only to the radiation fields without radiologically confirmed progression of the disease within the radiation fields after completion of prior radiotherapy. PRIOR THERAPY: - Time between end of (Neo)adjuvant chemotherapy and relapse < 6 months - Less than 6 weeks or 3 weeks respectively from prior radiotherapy or surgery to time of randomization - Treatment with an investigational agent within 4 weeks (6 weeks for immunotherapy) of study enrollment BIOLOGICAL CRITERIA: - Total Bilirubin > 1.0 x UNL - Creatinine > ou = 1.0 x UNL, or calculated creatinine clearance < 60 ml/min if creatinine > 1.0 x UNL and < ou = 1.5 UNL PAST or CURRENT HISTORY - Symptomatic brain metastases or leptomeningeal disease - History of another neoplasm except non metastatic melanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy < 5 years prior to randomization. - History of inflammatory bowel disease, significant bowel obstruction. - History of hypersensitivity grade 3 to platinum, gemcitabine or taxanes, polysorbate 80, or to compounds with similar chemical structures. - Any other active illness such as uncontrolled infections, uncontrolled cardiac disease or hypertension, uncontrolled diabetes that would preclude safe administration of study therapy at the time of randomization. CONCOMITANT TREATMENT - Concurrent treatment with strong inhibitors of CYP P450 3A4. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization
研究者
相似试验
Unknown
3 期
arotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer (CILAB)CTRI/2008/091/000036Sanofi Synthelabo India Limited900
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Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer - CILABocally Advanced/Metastatic Urothelial Tract or Bladder CancerMedDRA version: 9.1Level: LLTClassification code 10005003Term: Bladder cancerEUCTR2007-001943-23-FRSanofi-Aventis Recherche et Développement900
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Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer - CILABocally Advanced/Metastatic Urothelial Tract or Bladder CancerMedDRA version: 9.1Level: LLTClassification code 10005003Term: Bladder cancerEUCTR2007-001943-23-NLSanofi-Aventis Recherche et Développement900
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Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer.------------------------------------------------------------------------------------------------------Estudio aleatorizado de LAROTAXEL + Cisplatino (LC) versus Gemcitabina + Cisplatino (GC) en el tratamiento de primera línea de cáncer del tracto urotelial o vejiga localmente avanzado / metastásico. - CILABocally Advanced/Metastatic Urothelial Tract or Bladder Cancer.---------------------------------------------------------------------------------cáncer del tracto urotelial o vejiga localmente avanzado / metastásicoMedDRA version: 9.1Level: LLTClassification code 10005003Term: Bladder cancerEUCTR2007-001943-23-ESSanofi-Aventis Recherche et Développement900