A Phase I Trial of HDFL48(Weekly 48-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin) in Recurrent or Metastatic Colorectal Cancers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose and dose limiting toxicity
研究概览
简要总结
To determine the maximum tolerated dose and dose limiting toxicity of 5-FU and leucovorin with novel 48-hour infusion schedule, and to collect toxicity profile at different dose level of 5-FU/LV 48-hour infusion.
详细描述
Colorectal cancer is one of the major in Taiwan.It caused 3128 deaths in 1999, and represented the No.3 cancer killer in both male and female population of Taiwan.
Recently, evidence has accumulated that weekly, 24-hour infusion of high-dose 5-FU may improve the response rate and survival time compared with 5-FU bolus regiment. In a randomized multicenter trial of metastatic colorectal cancer, Kohne et al reported an overall response rate of 44%and a median survival time of 16 months using a weekly-times-six schedule of infusional 5-FU (2600mg/m2 24-hours infusion). In another randomized study for advanced colorectal cancer, de Gramont et al reported a significantly better outcome in patients treated by a similar schedule which combined "bolus plus infusional" 5-FU compared to "bolus" 5-FU. These results suggest that 24-or 48-hour infusion of high-dose 5-FU is more effective than the conventional bolus schedules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Pathologically confirmed recurrent or metastatic colorectal adenocarcinoma
- •Patients are indicated for 5-FU (1st-line after recurrence/metastasis), OR have failed 5-FU ,treatment with other schedules
- •At least one bi-dimensionally measurable lesion(s)
- •Previous C/T, R/T >= 4 weeks
- •KPS > 50%
- •Age >= 18 years
- •Fasting TG > 70 mg/dL (within 7 days)
- •WBC >= 3,000/uL or ANC >= 1,500/uL
- •Plt >= 75,000/uL
- •Cre<= 1.5 mg/dL
- •Proteinuria < 1+
- •Normal T-bil
- •AST/ ALT <= 3.5-fold of ULN
排除标准
- •Concomitant anticancer therapy or radiotherapy
- •CNS metastasis
- •Pregnant women
- •Patients who have second malignancy
- •Symptomatic heart disease (significant arrhythmia, CHF or MI within 3 months of entry)
- •Active infection exists
- •Extensive liver disease or liver cirrhosis
- •Patients who refuse Port-A catheter implantation
研究组 & 干预措施
A
干预措施: 5-Fluorouracil, Leucovorin (Drug)
结局指标
主要结局
To determine the maximum tolerated dose and dose limiting toxicity
时间窗: 2000~2005
次要结局
- response(2000~2005)