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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312819
• Other study ID #: DVC1.03-HMO-CTIL
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 10, 2006
• Last updated: August 30, 2010
• Start date: March 2006
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• chemotherapy +/- disulfiram

Locations

Country	Name	City	State
Israel	Oncology Institute Meir Medical Center	Kfar Saba

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Augusta Hospital, Berlin

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Marikovsky M, Nevo N, Vadai E, Harris-Cerruti C. Cu/Zn superoxide dismutase plays a role in angiogenesis. Int J Cancer. 2002 Jan 1;97(1):34-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response disease free survival survival		3 years
Secondary	Clinical response
Secondary	treatment tolerance

External Links

•   main page of hadassah hospital - the main facility of this trial