NCT00166881已完成2 期
Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-dose 5-Fluorouracil/Leucovorin for Non-resectable Gastric Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.
详细描述
- To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen
- To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy
- To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients
- To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed gastric adenocarcinoma
- •Measurable or evaluable disease
- •No previous C/T
- •Age 16 ~ 75 years
- •Karnofsky Performance Status of 60%
- •4 weeks after R/T
- •Adjuvant C/T: the last dosing of C/T 6 months before enrollment
- •WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl
排除标准
- •CNS metastasis
- •Patients receive concomitant anti-cancer C/T or R/T
- •Patients who are pregnant and with an expected life expectancy less than 3 months
- •Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis
研究组 & 干预措施
A, 2, III
Experimental
Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL
干预措施: Docetaxel-Irinotecan (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Five years
次要结局
- Objective response rates (CR, PR)(Confirmed objective response after 4 weeks)
研究者
研究点 (1)
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