A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and paclitaxel in treating patients who have metastatic or recurrent cancer of the esophagus or stomach.
详细描述
OBJECTIVES:
- Determine the antitumor activity of irinotecan and paclitaxel in patients with metastatic or recurrent adenocarcinoma of the esophagus or stomach.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia vs adenocarcinoma of the rest of the stomach).
Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months thereafter.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gastro Esophogeal cohort
Patients with adenocarcinoma of the esophagus, gastroesophageal (GE) junction and gastric cardia (GE cohort)
The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.
Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.
Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.
干预措施: irinotecan hydrochloride (Drug)
Gastro Esophogeal cohort
Patients with adenocarcinoma of the esophagus, gastroesophageal (GE) junction and gastric cardia (GE cohort)
The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.
Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.
Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.
干预措施: paclitaxel (Drug)
Distal Stomach cohort
Patients with adenocarcinoma of the rest of the stomach (Distal Stomach cohort)
The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.
Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.
Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.
干预措施: irinotecan hydrochloride (Drug)
Distal Stomach cohort
Patients with adenocarcinoma of the rest of the stomach (Distal Stomach cohort)
The course length is 3 weeks. Treatment will continue until one or more of criteria listed in the protocol are met.
Irinotecan 225 mg/m2 will be infused over 90 minutes every three weeks.
Paclitaxel 100 mg/m2 will be infused over three hours following irinotecan infusion every three weeks.
干预措施: paclitaxel (Drug)
结局指标
主要结局
To determine the antitumor activity of irinotecan and paclitaxel in patients with unresectable adenocarcinoma of the esophagus and gastric cardia.
时间窗: 5 months
次要结局
- To evaluate the toxicities of irinotecan and paclitaxel in this patient population.(5 months)