A Phase IB Study in Patients With Metastatic Colorectal Cancer to Evaluate Pharmacodynamic Effects of Erlotinib and Safety and Efficacy of Erlotinib in Combination With Modified FOLFOX6 (mFOLFOX6) and Bevacizumab
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Number of patients that develop study drug related toxicity
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, 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. Erlotinib may help chemotherapy work better by making tumor cells more sensitive to the drugs. Giving erlotinib together with combination chemotherapy and bevacizumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with combination chemotherapy and bevacizumab as first-line therapy in treating patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the toxicity of erlotinib, mFOLFOX6, and bevacizumab in patients with metastatic colorectal cancer.
- Determine the efficacy of this regimen in these patients.
- Determine the feasibility of escalating the dose of erlotinib in order to maximize the likelihood of developing a grade 2 skin rash in select patients.
OUTLINE: This is a multicenter study.
- Single-agent erlotinib: Patients receive oral erlotinib once daily on days 1-14 (course 1).
- Erlotinib, modified FOLFOX6, and bevacizumab chemotherapy: Patients receive oral erlotinib* once daily on days 1-14, oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1 and 2 in course 2. Beginning in course 3, patients also receive bevacizumab IV over 30 minutes. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
NOTE: Patients who do not develop grade 2 toxicity after the first 3 courses (6 weeks) will have their erlotinib dose escalated.
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
Erlotinib, modified FOLFOX6, and bevacizumab
干预措施: bevacizumab (Biological)
Erlotinib, modified FOLFOX6, and bevacizumab
干预措施: erlotinib hydrochloride (Drug)
Erlotinib, modified FOLFOX6, and bevacizumab
干预措施: fluorouracil (Drug)
Erlotinib, modified FOLFOX6, and bevacizumab
干预措施: leucovorin calcium (Drug)
Erlotinib, modified FOLFOX6, and bevacizumab
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Number of patients that develop study drug related toxicity
时间窗: 3 courses (6 weeks)
Dose-limiting toxicities will be tracked in the first three cycles. The occurrence of DLT in 2 of the first 6 patients, 3 of the first 9 patients, or 4 of the first 12 patients (whichever occurs soonest)will require that subsequent patients are enrolled to the study at 100 mg erlotinib daily.
次要结局
- Patient Response to Treatment Measured by RECIST Criteria(3 courses (6 weeks))
- Number of patients that can increase the erlotinib dose to 200mg(14 days)
研究者
Smitha Krishnamurthi
Principal Investigator
Case Comprehensive Cancer Center