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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Keywords

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Non-small cel lung cancer chemotherapy randomized phaseII disulfiram antiangiogenesis placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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chemotherapy +/- disulfiram

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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HadassahHMO

Principal Investigators

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Hovav Nechushtan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Center Ein Kerem

Nili Peylan-Ramu, MD

Role: STUDY_CHAIR

Hadassah Ein Kerem Medical Center

Maya Gotfrid, MD

Role: STUDY_CHAIR

Meir Medical Center Kfar Saba

Locations

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Oncology Institute Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

References

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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. doi: 10.1002/ijc.1565.

Reference Type BACKGROUND

PMID: 11774241 (View on PubMed)

Nechushtan H, Hamamreh Y, Nidal S, Gotfried M, Baron A, Shalev YI, Nisman B, Peretz T, Peylan-Ramu N. A phase IIb trial assessing the addition of disulfiram to chemotherapy for the treatment of metastatic non-small cell lung cancer. Oncologist. 2015 Apr;20(4):366-7. doi: 10.1634/theoncologist.2014-0424. Epub 2015 Mar 16.

Reference Type DERIVED

PMID: 25777347 (View on PubMed)

Other Identifiers

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DVC1.03-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id