Trial Information

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

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.