NCT00139243已完成1 期
A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
研究概览
简要总结
The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.
详细描述
- Patients will be premedicated at home with dexamethasone and leucovorin.
- On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy.
- During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle.
- At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end. If significant reduction in the size of the tumor is observed, a third and final cycle will be done.
- After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.
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
- •Histologic documentation of squamous cell carcinoma of head and neck
- •Patients will previously untreated stage III or IV squamous cell carcinoma.
- •Patients with locally recurrent disease after surgery.
- •Life expectancy of longer than 3 months.
- •Kidney function: 1.5 or a 24 hour creatinine clearance of > 30ml/min
- •Liver function: SGOT < 1.5 X upper normal limit and alkaline phosphatase of < 2.5 X upper normal limit.
- •WBC greater than or equal to 4,000/mm
- •Platelet count greater than or equal to 100,000/mm
- •Hemoglobin greater than or equal to 10gm/dl
- •Patients of child-bearing age must use effective methods of contraception.
排除标准
- •Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
- •Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
- •Pregnant or breast-feeding women
结局指标
主要结局
To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
次要结局
- To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
- to obtain preliminary information about the effectiveness of the drug combination.
研究者
研究点 (4)
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