A Phase I/II Study on the Treatment With Taxotere in Combination With Xeloda in Patients With Metastatic Oesophageal Cancer or Cancer in the Cardia Region
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 93
- 试验地点
- 10
- 主要终点
- Response rate
研究概览
简要总结
This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of Taxotere in combination with Xeloda which is dose escalated during the first phase of the study (modified Fibonacci design) and fixed during the second phase.
The primary objective of the phase 1 part is to define the dose recommended for the Phase II part of the study. The primary objective is to determine the response rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia.
- •Inoperable metastatic disease
- •Performance status (WHO) of 0-2
- •Measurable disease.
- •Adequate hematological, liver and renal function.
- •Signed informed consent.
排除标准
- •CNS metastases
- •Symptomatic peripheral neuropathy equal to or greater than NCI grade
- •Other concomitant serious illness or medical condition.
- •Past or current history of malignant neoplasm other than oesophageal carcinoma.
- •<18 years of age. Pregnant or lactating patients.
研究组 & 干预措施
Taxotere Xeloda
Taxotere i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule.
Xeloda orally day 1-14 every 3 weeks.
干预措施: Docetaxel (Drug)
Taxotere Xeloda
Taxotere i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule.
Xeloda orally day 1-14 every 3 weeks.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Response rate
Response rate will be defined as the percentage of patients who achieve a complete response (CR) or partial response (PR). Duration of a CR or PR will be calculated from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.
次要结局
- Quality of life(Every three weeks)
- CT scan(Every 9 weeks)
- Toxicity assessment(Every three weeks)
研究者
Signe Friesland
MD, PhD
Karolinska University Hospital