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

Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-small Cell Lung Cancer

Intervention: chemotherapy +/- disulfiram (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Hovav Nechushtan, MD, PhD, Principal Investigator, Affiliation: Hadassah Medical Center Ein Kerem
Nili Peylan-Ramu, MD, Study Chair, Affiliation: Hadassah Ein Kerem Medical Center
Maya Gotfrid, MD, Study Chair, Affiliation: Meir Medical Center Kfar Saba

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).

Clinical Details

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

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

Primary outcome: tumor response disease free survival survival

Secondary outcome:

Clinical response

treatment tolerance

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Oncology Institute Meir Medical Center, Kfar Saba, Israel
Additional Information

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

Related publications:

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.

Starting date: March 2006
Last updated: August 30, 2010

Page last updated: August 20, 2015

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