Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS.
详细描述
Gastric cancer is a major killer in oncology. The expected overall survival of metastatic patients is less than 2 years. Moreover, most of the patients develop cachexia and worsening of performance over time. As a result, many patients are not fit for second line treatment when eligible. There is currently no approved consensus for third line treatment regimen and in most of the patients it is usually best supportive care.
Irinotecan and docetaxel were tested as single agents or in combination with other drugs (e.g. FOLFIRI) in second line setting. However, the combination of these two drugs together was not tested before. Both agents are active in second line setting which is considered the last chance of the patient in view of lack of evidence in third line setting.
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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological evidence of adenocarcinoma of the stomach
- •Metastatic disease or locally advanced non-resectable disease
- •Patients who received only one line of treatment
- •Performance status 0,1,2 as per ECOG scoring system
排除标准
- •Patients who received docetaxel or irinotecan before recruitment to this study
- •Multiple comorbid conditions
- •Liver or kidney impairment
- •Severe cachexia (sarcopenia)
研究组 & 干预措施
Chemotherapy
Second line treatment will be as follows
- Docetaxel at 30 mg/m2 over 500 cc normal saline over 1 hour infusion
- Irinotecan at 185 mg/m2 with a maximum of 300 mg given over 500 cc normal saline over 2 hours infusion
- The whole regimen is to be cycled every 2 weeks for a maximum of 6 months with interim and end of treatment evaluation
干预措施: Docetaxel (Drug)
Chemotherapy
Second line treatment will be as follows
- Docetaxel at 30 mg/m2 over 500 cc normal saline over 1 hour infusion
- Irinotecan at 185 mg/m2 with a maximum of 300 mg given over 500 cc normal saline over 2 hours infusion
- The whole regimen is to be cycled every 2 weeks for a maximum of 6 months with interim and end of treatment evaluation
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 6 months from chemotherapy
described according to RECIST criteria
次要结局
- Quality of life (QoL)(three months and six months from chemotherapy)
- Progression free survival (PFS)(One year from start of enrollment)
- Overall survival (OS)(One year from start of enrollment)
研究者
Ahmed Sohaib
Principal investigator, Lecturer of Clinical oncology
Menoufia University