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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 11, 2006
Last Update Posted: August 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Augusta Hospital, Berlin
Information provided by:
Hadassah Medical Organization
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).

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: chemotherapy +/- disulfiram Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Trial of Treatment of Advanced Non Small Cell Lung Carcinoma With/Without Disulfiram and Cisplatin Navelbine

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • tumor response disease free survival survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Clinical response
  • treatment tolerance

Estimated Enrollment: 60
Study Start Date: March 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312819

Oncology Institute Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Augusta Hospital, Berlin
Principal Investigator: Hovav Nechushtan, MD, PhD Hadassah Medical Center Ein Kerem
Study Chair: Nili Peylan-Ramu, MD Hadassah Ein Kerem Medical Center
Study Chair: Maya Gotfrid, MD Meir Medical Center Kfar Saba
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: hovav nechushtan, HadassahHMO
ClinicalTrials.gov Identifier: NCT00312819     History of Changes
Other Study ID Numbers: DVC1.03-HMO-CTIL
First Submitted: April 10, 2006
First Posted: April 11, 2006
Last Update Posted: August 31, 2010
Last Verified: February 2009

Keywords provided by Hadassah Medical Organization:
Non-small cel lung cancer
randomized phaseII

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action