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临床试验/NCT00312819
NCT00312819已完成2 期

Randomized Phase 2 Trial of Treatment of Advanced Non Small Cell Lung Carcinoma With/Without Disulfiram and Cisplatin Navelbine

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年3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
60
试验地点
1
主要终点
tumor response disease free survival survival

研究概览

简要总结

Recent studies in laboratory animals demonstrate the ability of disulfiram to significantly inhibit the growth and metastasis of a mouse model of lung cancer. Work with cells in vitro support the idea that this inhibition is mainly due to the inhibition of angiogenesis - the formation of new blood vessels in the tumor. Furthermore, it was found out that the best effect has been obtained when disulfiram has been used not at the highest dose but at an optimal dose, which is smaller. Thus, this trial will assess the addition of disulfiram to chemotherapy in non-small cell lung cancer (NSCLCA).

详细描述

Metastatic non small cell lung cancer remains a deadly disease with median survival times of several months. Any treatment which can prolong patients' survival without causing severe side effects is of course an important addition to our limited arsenal in the fight against this disease. A recent article by Marikowsky and colleagues extended significantly our knowledge regarding the possible activity of disulfiram (well known in its commercial name Antabuse) as an anticancer agent (Marikowsky et al Int J of cancer 97 :34 2002). In this article it was demonstrated that disulfiram has potent antitumor activity and that it can act as a significant inhbitor of angiogenesis.

Since disulfiram has been well tolerated by thousands of patients, and there are observations that anti angiogenic therapy enhances the effect of chemotherapy (for example bevacizumab in combination with chemotherapy in colon carcinoma) we decided to conduct a clinical trial assessing the effect of the addition of this drug at moderate doses to chemotherapy which is used as one of the standard therapies in lung cancer. In order to obtain information regarding the effect of the addition of this drug, only 50% of the patients will be treated with the drug and the rest will be treated with placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Metastatic non-small cell lung cancer
  • Previously untreated
  • ECOG performance status (PS) 0-1
  • Liver function tests within the norm

排除标准

  • Willingness to abstain from alcohol
  • Not pregnant
  • Without a psychiatric history

结局指标

主要结局

tumor response disease free survival survival

时间窗: 3 years

次要结局

  • treatment tolerance
  • Clinical response

研究者

申办方类型
Other

研究点 (1)

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