A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 46
- 主要终点
- Proportion of patients with R0 resection after treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine 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 tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab before and after surgery may be an effective treatment for liver metastases.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with bevacizumab works in treating patients who are undergoing surgery for liver metastases due to colorectal cancer.
详细描述
OBJECTIVES:
- Determine the proportion of patients with resectable hepatic metastases secondary to colorectal cancer who undergo surgical resection and achieve a R0 resection after treatment with neoadjuvant capecitabine, oxaliplatin, and bevacizumab.
- Determine the probability of non-progression (i.e., stable disease or response [complete and partial, confirmed and unconfirmed]) in patients treated with this regimen.
- Compare the proportion of patients treated with this regimen who undergo surgical resection and those who achieve a R0 resection with that described in the literature.
- Determine overall survival and disease-free survival of patients treated with this regimen.
- Determine response by positron emission tomography in patients treated with this regimen.
- Correlate clinical outcome with expression of biomarkers (e.g., thymidylate synthase, dihydropyrimidine dehydrogenase, thymidine phosphorylase, excision repair cross complementing 1, and hTERT) and telomere length in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy: Patients receive bevacizumab* IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *Bevacizumab is administered during courses 1-3 of neoadjuvant therapy.
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
Chemotherapy + Surgery + Chemotherapy
Preoperative Neoadjuvant Chemotherapy
- Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3
- Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
- Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
Conventional surgery: After 4 cycles of chemotherapy
Postoperative Neoadjuvant Chemotherapy
- Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4
- Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
- Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
干预措施: bevacizumab (Biological)
Chemotherapy + Surgery + Chemotherapy
Preoperative Neoadjuvant Chemotherapy
- Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3
- Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
- Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
Conventional surgery: After 4 cycles of chemotherapy
Postoperative Neoadjuvant Chemotherapy
- Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4
- Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
- Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
干预措施: capecitabine (Drug)
Chemotherapy + Surgery + Chemotherapy
Preoperative Neoadjuvant Chemotherapy
- Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3
- Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
- Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
Conventional surgery: After 4 cycles of chemotherapy
Postoperative Neoadjuvant Chemotherapy
- Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4
- Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
- Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
干预措施: oxaliplatin (Drug)
Chemotherapy + Surgery + Chemotherapy
Preoperative Neoadjuvant Chemotherapy
- Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3
- Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
- Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
Conventional surgery: After 4 cycles of chemotherapy
Postoperative Neoadjuvant Chemotherapy
- Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4
- Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
- Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Proportion of patients with R0 resection after treatment
时间窗: 16-18 weeks from registration
Comparison of patients achieving R0 resection with literature
时间窗: 16-18 weeks from registration
Overall survival
时间窗: Up to 3 years
Probability of nonprogression (i.e., stable disease or response [complete and partial, confirmed and unconfirmed])
时间窗: 12 weeks from registration
Disease-free survival
时间窗: Up to 3 years
Positron emission tomography response
时间窗: Registration and 12 weeks
Correlation of clinical outcome with expression of biomarkers and telomere length
时间窗: Up to 3 years
次要结局
未报告次要终点