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

Phase 2/Phase 3
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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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.

Inclusion Criteria:

- Metastatic non-small cell lung cancer

- Previously untreated

- ECOG performance status (PS) 0-1

- Liver function tests within the norm

Exclusion Criteria:

- Over 18

- Willingness to abstain from alcohol

- Not pregnant

- Without a psychiatric history

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

tumor response disease free survival survival

Outcome Time Frame:

3 years

Principal Investigator

Hovav Nechushtan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Center Ein Kerem


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

March 2006

Completion Date:

December 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cel lung cancer
  • chemotherapy
  • randomized phaseII
  • disulfiram
  • antiangiogenesis
  • placebo
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms