NCT00881101Unknown1 期
Dose Escalation Study of Liposomal Paclitaxel in Chinese Patients With Advanced Solid Tumors
Nanjing Sike Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年4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
- 15
- 试验地点
- 1
- 主要终点
- maximum tolerated dose
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.
详细描述
There are clinical trials show that paclitaxel is common option for the treatment of solid tumors. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional paclitaxel. However,the tolerance of this new dosage form of paclitaxel (liposomal paclitaxel) has never been studied in Chinese cancer patients. This study is designed to find the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese cancer patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: from 18 to 70
- •Patients with solid tuomors at advanced stage must be histologically or cytologically confirmed ,and be suitable for treating with Paclitaxel Liposome solo
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS)is from 0 to 2
- •Patients who are expected to live at least 3 months
- •Laboratory tests before the study: white blood count (WBC)≥4,000/mm³,absolute neutrophil count (ANC) ≥1,500/mm³, platelet count ≥100,000/mm³, hemoglobin≥9.0 g/dL, aspartate aminotransferase AST (sGOT) and alanine aminotransferase ALT(sGPT)≤2.5 times of normal value upper limit，serum creatinine≤1.0 time of normal value upper limit，total bilirubin≤1.5 times of normal value upper limit
- •Not using chemotherapeutics (including test drug)before the study trial at least 4 weeks
- •No obvious functional disturbance diseases of internal organs
- •Complying with the study protocol
- •Sign informed consent
- •No Previous anaphylactic reaction to hormone
排除标准
- •Allergy to any medication or foods; History of hypersensitivity reactions to the conventional dosage form of paclitaxel or correlate excipients
- •Active uncontrolled central nervous system metastasis
- •Severe complications that obviously influence the compliance of patients
- •Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
- •Taking other study medications or participating other clinical trial within 4w
- •Having radiation therapy or operation within 4w
- •Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation therapy) (except alopecie and hemoglobin)
- •Pregnant or lactant women; fertile patients not using effective contraception during study
- •No chief organ functional disturbance or diseases:
- •abnormal liver and renal functions
- •myocardial infarction
- •active heart disease
- •neuropathy or mental diseases including dementia or epilepsy
- •blind、deaf、dumb or extremity disability
- •known infection
- •active diffuse intravascular coagulation
- •Others whom researchers regard not eligible for the study.
研究组 & 干预措施
1
Experimental
Liposomal paclitaxel
干预措施: Liposomal paclitaxel (Drug)
结局指标
主要结局
maximum tolerated dose
时间窗: 6 months
次要结局
- dose limiting toxicity(6 months)
研究者
研究点 (1)
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