A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 28
- 主要终点
- Proportion of successes
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 of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.
详细描述
OBJECTIVES:
- Determine the objective tumor response rate in patients with metastatic gastric or gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine whether interleukin-1 polymorphisms are present among patients who have weight loss vs no weight loss, and their relationship to a poor prognosis.
- Assess the quality of life and swallowing uniscale during chemotherapy in these patients.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment.
Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.
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
docetaxel + capecitabine
Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment.
Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.
干预措施: capecitabine (Drug)
docetaxel + capecitabine
Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment.
Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.
干预措施: docetaxel (Drug)
结局指标
主要结局
Proportion of successes
时间窗: Up to 3.5 years
次要结局
- Survival time(Up to 3.5 years)
- Time to disease progression(Up to 3.5 years)
- Duration of response(Up to 3.5 years)
- Time to treatment failure(Up to 3.5 years)
- Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires(Up to 3.5 years)