A Phase II Study of Taxotere and Irinotecan (CPT-11) in Patients With Advanced Adenocarcinoma of the Lower Esophagus, Esophagogastric Junction, and Gastric Cardia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 19
- 主要终点
- objective tumor response rate
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.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and irinotecan in treating patients who have advanced cancer of the esophagus or stomach.
详细描述
OBJECTIVES: I. Determine the objective tumor response rate in patients with advanced adenocarcinoma of the lower esophagus, esophagogastric junction, and gastric cardia treated with docetaxel and irinotecan. II. Determine time to progression and overall survival of patients treated treated with this regimen. III. Determine the toxic effects of this regimen in these patients. IV. Assess treatment response in these patients by determining the prevalence of dysphagia, anorexia, and swallowing ability at diagnosis and during treatment with this regimen.
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 —（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
irinotecan + docetaxel
Patients receive irinotecan IV over 90 minutes followed by docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
Patients achieving a complete response (CR) receive 2 additional courses after CR. Patients experiencing disease progression after a CR and 2 additional courses may be retreated with irinotecan and docetaxel. Dysphagia, anorexia, and swallowing ability are assessed before the first course of treatment and then at each tumor assessment.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: docetaxel (Drug)
irinotecan + docetaxel
Patients receive irinotecan IV over 90 minutes followed by docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression.
Patients achieving a complete response (CR) receive 2 additional courses after CR. Patients experiencing disease progression after a CR and 2 additional courses may be retreated with irinotecan and docetaxel. Dysphagia, anorexia, and swallowing ability are assessed before the first course of treatment and then at each tumor assessment.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
objective tumor response rate
时间窗: Up to 5 years
次要结局
- time to progression(Up to 5 years)
- overall survival(Up to 5 years)
- treatment response(Up to 5 years)