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

This study has been completed.
Sponsor:
Collaborator:
Augusta Hospital, Berlin
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00312819
First received: April 10, 2006
Last updated: August 30, 2010
Last verified: February 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312819

Locations
Israel
Oncology Institute Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Augusta Hospital, Berlin
Investigators
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:
Responsible Party: hovav nechushtan, HadassahHMO
ClinicalTrials.gov Identifier: NCT00312819     History of Changes
Other Study ID Numbers: DVC1.03-HMO-CTIL
Study First Received: April 10, 2006
Last Updated: August 30, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Non-small cel lung cancer
chemotherapy
randomized phaseII
disulfiram
antiangiogenesis
placebo

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Disulfiram
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014