跳至主要内容
临床试验/NCT00205322
NCT00205322已完成2 期

A Phase II Study of Oxaliplatin, 5-fluorouracil, and Leucovorin in Combination With Oral Capecitabine in Patients With Metastatic Colorectal Cancer

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2004年4月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
45
试验地点
2
主要终点
Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients

研究概览

简要总结

The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both patient convenience and lack of associated catheter-related complications.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • no prior treatment for metastatic disease
  • measurable disease

排除标准

  • neuropathy > or equal to grade 2
  • concomitant radiation therapy or other systemic cancer therapies
  • brain mets

结局指标

主要结局

Does the combination of oxaliplatin, 5-FU, leucovorin and capecitabine improve the activity of the FOLFOX regimens in metastatic colorectal cancer patients

时间窗: Bi-monthly collection of information regarding tumor progression and overall survival.

次要结局

  • Is the oral drug an advantage in this patient population(Bi-monthly collection of information regarding tumor progression and overall survival)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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