Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
研究概览
简要总结
This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.
详细描述
<Phase I>
Primary Objective:
To establish the safety of combination chemotherapy comprising docetaxel (escalating doses: 25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil (600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objective:
To observe the efficacy of this regimen in these 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan
- •ECOG performance status 0-1
- •20 years and older
- •Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor
- •Tissue from tumor must be available
- •Patients must have measurable disease
- •Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month
- •Life expectancy > 3 months
- •Laboratory values as follows
- •3000/mm3 < WBC < 12000/mm3
- •1500/mm3 < granulocyte count
- •8.0 gm/dl < hemoglobin
- •Platelet count > 100000/mm3
- •Aspartate transaminase < 150 IU/L
- •Alanine transaminase < 150 IU/L
- •Creatinine < 1.5 mg/dl
- •Able and willing to give valid written informed consent
排除标准
- •Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception)
- •Active or uncontrolled infection
- •Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week
- •Clinically significant heart disease
- •Patients with a history of myocardial infarction within the previous three months
- •Patients with uncontrolled diabetes mellitus or hypertension
- •Presence of clinically apparent central nervous system metastases
- •Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •Decision of unsuitableness by principal investigator or physician-in-charge
研究组 & 干预措施
Anticancer drug
docetaxel, cisplatin and 5-FU
干预措施: DCF (Drug)
结局指标
主要结局
Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
时间窗: 1 month
次要结局
- To determine the recommended phase II dose of docetaxel (Phase I)(1 month)
- To determine the clinical effectiveness in the patients with measurable disease (Phase I)(1 month)
- To analyze the toxicity (Phase II)(1 month)
- Time to progression (Phase II)(5 years)
- median survival time (Phase II)(5 years)