Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312819
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2006-04-10
Brief Title:
Initial Assessment of the Effect of the Addition of Disulfiram Antabuse to Standard Chemotherapy in Lung Cancer
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Randomized Phase 2 Trial of Treatment of Advanced Non Small Cell Lung Carcinoma WithWithout Disulfiram and Cisplatin Navelbine
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None