ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.
研究概览
简要总结
To determine efficacy in the delivery of chronomodulated chemotherapy.
详细描述
The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study.
It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.
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 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological proof of adenocarcinoma in primary colon or rectum tumor.
- •Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
- •Ages 18 to 86 years.
- •Presence of at least one bi-dimensionally measurable disease with at least one diameter > or = 2 cm.
- •WHO/ECOG performance status < 3 (0, 1, or 2)
- •Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted.
- •Signed informed consent
排除标准
- •Peripheral sensory neuropathy > or = grade
- •Serum bilirubin (total) > 3 X ULN.
- •Symptomatic or uncontrolled brain metastasis.
- •Metastases limited to bone, pleural effusion, or ascites.
- •Uncontrolled overt cardiac disease.
- •Uncontrolled hypercalcemia.
- •Uncontrolled infections.
- •Uncontrolled hypertension (>180/110)
- •History of GI perforation.
- •History of arterial thromboembolic events.
- •History of congestive heart failure.
- •Patients taking warfarin (Coumadin).
- •Patients who are pregnant.
结局指标
主要结局
The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.
时间窗: 2 years
次要结局
未报告次要终点