Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
详细描述
This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 20-74 years of age
- •Histologically confirmed colorectal cancer
- •Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease
- •At least one measurable lesion according to RECIST
排除标准
- •Evidence of clinically detectable ascites at study treatment start
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.
- •Evidence of bleeding diathesis or coagulopathy
- •Serious, non-healing wound, ulcer, or bone fracture
- •Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration
研究组 & 干预措施
Step 3
干预措施: Bevacizumab (Drug)
Step 1
干预措施: Oxaliplatin (Drug)
Step 1
干预措施: Capecitabine (Drug)
Step 2
干预措施: Bevacizumab (Drug)
Step 2
干预措施: Oxaliplatin (Drug)
Step 2
干预措施: Capecitabine (Drug)
Step 3
干预措施: Oxaliplatin (Drug)
Step 3
干预措施: Capecitabine (Drug)
结局指标
主要结局
Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: event driven
Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
时间窗: throughout study
次要结局
- time to progression(event driven)
- overall survival(event driven)
- time to response(event driven)
- duration of response(event driven)
- concentrations of R340 and its metabolites(throughout study)
- concentrations of platinum(throughout study)
- concentrations of bevacizumab(throughout study)
- concentrations of vascular endothelial growth factor (VEGF)(throughout study)
- concentrations of anti-bevacizumab antibody(throughout study)