NCT00101608已完成2 期
A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium
Bristol-Myers Squibb2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy.
研究概览
简要总结
The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.
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
- •Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).
- •Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
- •Adequate performance status (Karnofsky greater or equal to 80).
排除标准
- •Receipt of more than 1 prior chemotherapy regimen in any setting.
- •Prior discontinuation of platinum due solely to toxicity.
- •Current neuropathy greater or equal to CTC grade
- •Prior radiation to greater or equal to 30% of bone marrow.
- •Inadequate hematologic function: ANC <1,500 cells/mm3, Platelet<100,000 cells/mm
- •Inadequate hepatic function: total bilirubin > 1.5 times ULN, ALT/AST > 2.5 times ULN or > 5 times ULN in case of liver metastasis.
- •Inadequate renal function: creatinine clearance <20 ml/min.
- •Prior allergy to any vinca-alkaloid.
研究组 & 干预措施
1
Experimental
干预措施: vinflunine (Drug)
结局指标
主要结局
To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy.
时间窗: 10-Apr-2007
次要结局
- To estimate duration of response, time to response disease control rate, progression free survival, and overall survival in this patient population, and evaluate the safety profile of vinflunine(10-April-2007)
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
A Study of Vinflunine in Patients With Gastric CancerStomach CancerNCT00359476Bristol-Myers Squibb55
已完成
2 期
Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial CancerCarcinoma, Transitional CellNCT01529411Spanish Oncology Genito-Urinary Group86
已完成
1 期
Vinflunine and Erlotinib or Pemetrexed in Treating Patients With Unresectable or Metastatic Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00320073UNC Lineberger Comprehensive Cancer Center41
已完成
2 期
Vinorelbine for Children With Progressive or Recurrent Low-grade GliomasLow-grade GliomaNCT01497860Eugene Hwang13
进行中（未招募）
不适用
A Phase II Study of Intravenous (IV) Vinflunine in Patients with Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the UrotheliumRevised Protocol #05, incorporating Protocol Amendments 04, 07, 08 and 10;+ Pharmacokinetics Blood Sample Amendment #03 dated 18-Oct-05+ Amendment #06, dated 24-Feb-06Advanced Cancer, IV, NosEUCTR2005-001463-64-SEBristol-Myers Squibb International Corporation150