A Phase II Study of Weekly Paclitaxel, Cisplatin and 24-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin(Weekly TP-HDFL) in the Treatment of Advanced Transitional Cell Carcinoma(TCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced transitional cell carcinoma in terms of response rate and overall survival.
详细描述
Transitional cell carcinoma(TCC)of urothelium,including bladder, ureter, and renal pelvis TCCs, was the most lethal urology malignancy in Taiwan. In 1995, approximately 1,300 new cases of TCC was diagnosed in Taiwan and more than 600 patients died of this disease. Advanced TCC is a moderately chemosensitive disease. A combination of methotrexate, vinblastine, and cisplatin with or without doxorubicin (M-VAC or CMV) has been widely used since 1980s. Despite the response rate was as high as 40-70%, the survival of these patients was only slightly increased from a median of 7 to 9 months for those who were treated with supportive care or cisplatin alone to a median of 12 months by cisplatin-based combination chemotherapy. One of the reasons for the poor treatment results is the inevitable treatment-related toxicities related to conventional systemic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC
- •Measurable disease
- •Creatinine clearance>35ml/min,
- •AST/ALT < or = 3.5times upper limits of normal reference values
- •Bilirubin< or = 2.0 mg/dl
- •WBC > or = 4,000/mm3, PLT > or = 100,000/mm3
- •Written informed consent
排除标准
- •Previous systemic chemo is not allowed
- •TG <70mg/dl
- •CNS metastasis
- •Life expectancy less than 3 months
研究组 & 干预措施
A
干预措施: Paclitaxel, Cisplatin, 5-Fluorouracil (Drug)
结局指标
主要结局
response rate
时间窗: 2000~2005
次要结局
- Overall Survival ,Safety(2000~2005)
