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Completed

NCT Number: NCT00312819

Initial Assessment of the Effect of the Addition of Disulfiram (Antabuse) to Standard Chemotherapy in Lung Cancer

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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oncology Institute Meir Medical Center

Kfar Saba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chemotherapy +/- disulfiram

Drug

Primary outcomes

  1. tumor response disease free survival survival

    Time frame: 3 years

Secondary outcomes

  1. Clinical response

  2. treatment tolerance

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Augusta Hospital, Berlin

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 11, 2006
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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