A Phase II Study of Depsipeptide (NSC-630176) In Patients With Advanced Transitional Cell Carcinoma Of The Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen For Advanced Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Probability of response (confirmed complete and partial)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with advanced cancer of the urothelium that has progressed or recurred after receiving one chemotherapy regimen.
详细描述
OBJECTIVES:
- Determine the response (confirmed complete and partial) in patients with advanced transitional cell carcinoma of the urothelium that has progressed after prior chemotherapy when treated with FR901228 (depsipeptide) .
- Determine progression-free and overall survival of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine, preliminarily, the effects of this drug on reversing tumor promoter gene methylation in these patients.
- Correlate, preliminarily, tumor DNA in plasma with response or outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response receive 2 additional courses of treatment.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment
Depsipeptide
干预措施: Depsipeptide (Drug)
结局指标
主要结局
Probability of response (confirmed complete and partial)
时间窗: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
次要结局
- Progression-free survival(From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years)
- Overall survival(From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years)
- Number and grade of adverse events(From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years)