A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
研究概览
简要总结
The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.
详细描述
Patients will receive temozolomide orally once daily for one week, followed by a one-week rest period. This one-week on/one week off schedule will continue for the duration of treatment unless significant side effects develop.
Bevacizumab will be administered intravenously every other week. After eight weeks (two cycles), a CT scan will be performed to see how treatment affected tumor growth.
Bactrim, an antibiotic, and acyclovir, an antiviral medicine, will be given in order to help prevent infection.
Blood tests will be done every other week to evaluate any side effects.
Once the study has been completed, a physical exam, vital signs, blood tests, and CT scan will be performed.
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 documented locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
- •Measurable disease > 1cm by spiral computed tomography (CT) or > 2cm by other radiographic technique
- •ECOG performance status of 0-2
- •Life expectancy of > 12 weeks
- •Prior treatment with chemotherapy is allowed
- •Total bilirubin < 2.0mg/dl
- •AST < 5x upper limit of normal (ULN)
- •Serum creatinine < 2.0mg/dl
- •Absolute neutrophil count > 1,000/mm3
- •Platelets > 100,000/mm3
- •International Normalized Ratio (INR) < 1.5
排除标准
- •Prior treatment with temozolomide, decarbazine or bevacizumab
- •Clinically apparent central nervous system metastases or carcinomatous meningitis
- •Clinically significant cardiovascular disease
- •Major surgery, open biopsy, or significant traumatic injury within 28 days
- •Pregnant or breast-feeding women
- •Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medication
- •Serious, nonhealing wound, ulcer or bone fracture
- •Evidence of bleeding diathesis or coagulopathy
- •History of other disease or metabolic dysfunction
结局指标
主要结局
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
时间窗: 2 years
次要结局
- To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
研究者
Matthew H. Kulke, MD
Principal Investigator
Dana-Farber Cancer Institute