A Pilot Study of FOLFOX in Combination With Bevacizumab in Patients With Advanced Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of neuroendocrine tumors by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with advanced neuroendocrine tumors.
详细描述
OBJECTIVES:
Primary
- Determine the safety of fluorouracil, leucovorin calcium, and oxaliplatin (FOLFOX) with bevacizumab in patients with advanced neuroendocrine tumors.
- Determine the best overall response rate in patients treated with this regimen.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the time to treatment failure and progression in patients treated with this regimen.
- Determine the biochemical marker response in patients treated with this regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FOLFOX with Bevacizumab
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
干预措施: leucovorin (Drug)
FOLFOX with Bevacizumab
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
干预措施: bevacizumab (Biological)
FOLFOX with Bevacizumab
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
干预措施: 5-fluorouracil (Drug)
FOLFOX with Bevacizumab
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment
时间窗: From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years
Rates of discontinuation were calculated as counts and percentages of patients whom discontinued treatment due to adverse events possibly related to the investigational treatments not including neuropathy.
Best Objective Response
时间窗: From Baseline until disease progression, up to 8 years
Best Objective Response by RECIST with Exact 95% Binomial CIs across all tumor types. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria Target lesions response + Non-Target lesions response + Evaluation of non-target lesions (Yes / No) = Overall response
次要结局
- Time to Progression(From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years)
- Overall Median Survival(until death, up to 8 years)
- Overall Time to Treatment Failure(From initial complete or partial response to disease progression, up to 8 years)
- Biochemical Marker Response(From Baseline until end of treatment, up to 8 years)