NCT00639522Unknown1 期
A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.
Nanjing Sike Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
The purpose of this study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.
详细描述
The maximum tolerated dose (MTD) and pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) have never been studied in Chinese cancer patients, either alone or with capecitabine .This clinical trial is designed to find out the MTD and pharmacokinetics of liposomal paclitaxel with a beginning dose of 175mg/m2 with/without Capecitabine in Chinese patients with advanced gastric carcinoma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery;
- •No prior systemic chemotherapy with taxane at least 6 months before the recruitment;
- •At least one measurable tumor according to RECIST standard, with at least one diameter ≥20mm assessed by traditional imaging technique or MRI, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral CT; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- •Patients who are expected to live at least 3 months;
- •Obtaining informed consent;
排除标准
- •Receiving other chemotherapy or radiotherapy during the administration;
- •Symptomatic metastatic brain tumor;
- •Allergy to any study medication;
- •Pregnancy or breast feeding;
- •Severe heart diseases;
- •Uncontrolled mental diseases;
- •Abnormal liver and renal functions, which are measured by AST/ALT and BUN/Cr;
- •Neutrophils（ANC）<2000/μL;platelets<100，000/μL;hemoglobin（HB）<9.0 g/dL;
研究组 & 干预措施
A
Experimental
干预措施: Liposomal paclitaxel and capecitabine (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: 6 weeks
次要结局
- Pharmacokinetics(48 hours)
研究者
研究点 (1)
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