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 responsetreatment 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
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