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临床试验/NCT00052507
NCT00052507已完成2 期

A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer

University Health Network, Toronto8 个研究点 分布在 1 个国家开始时间: 2003年1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
试验地点
8

研究概览

简要总结

RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.

详细描述

OBJECTIVES:

  • Determine the efficacy of bortezomib, in terms of response rate and stable disease rate, in patients with recurrent or metastatic colorectal cancer.
  • Determine the toxicity of this drug in these patients.
  • Determine the time to progression and response duration in patients treated with this drug.
  • Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4 months.

研究设计

研究类型
Interventional
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

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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