Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer
研究概览
简要总结
The purpose of this study is to determine what effects (good and bad) bevacizumab (Avastin) and docetaxel (Taxotere), used in combination, have on metastatic gastric and esophageal cancer.
详细描述
Bevacizumab will be administered intravenously in an outpatient clinic once a week, every other week. Docetaxel will also be administered intravenously in the outpatient clinic once a week for three out of four weeks. Blood tests and vital signs will be performed weekly.
After the first eight weeks of therapy a CT scan will be performed to determine and assess the progress of the disease. If therapy is continued, radiological procedures will be performed at week 16 and every 8 weeks thereafter.
Treatment will be given for a minimum of 8 weeks, as long as the patient does not experience unacceptable side effects. Chemotherapy will continue for a year and a half as long as the cancer is responding and there are no unacceptable side effects.
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, unresectable or metastatic stage IV esophageal or gastric carcinoma
- •Measurable disease greater than or equal to 1cm by spiral computed tomography (CT) scan or greater than or equal to 2cm by other radiographic technique
- •ECOG performance status 0-2
- •One prior chemotherapy for metastatic disease permitted
- •White blood cell count greater than or equal to 3,000/mm
- •Absolute neutrophil count greater than or equal to 1,500/mm3
- •Platelet count greater than or equal to 100,000/mm3
- •Hemoglobin greater than or equal to 8.0g/dl
- •Creatinine less than 2.0mg/dL
- •Total bilirubin less than 1.9mg/dL
排除标准
- •Pregnant or lactating women
- •History or evidence of central nervous system (CNS) disease
- •Other active malignancies other than non-melanoma skin cancer or in-situ cervical cancer
- •History of severe hypersensitivity to docetaxel, bevacizumab or drugs formulated with polysorbate
- •Current, recent or planned treatment with standard chemotherapy, radiation therapy or another experimental therapy.
- •History of other disease or metabolic dysfunction.
- •Serious, non-healing wound, ulcer, or bone fracture.
结局指标
主要结局
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer
时间窗: 3 years
次要结局
- To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab
研究者
Peter C. Enzinger, MD
Principal Investigator
Dana-Farber Cancer Institute