Initial Assessment of the Effect of the Addition of Disulfiram (Antabuse) to Standard Chemotherapy in Lung Cancer
Randomized Phase 2 Trial of Treatment of Advanced Non Small Cell Lung Carcinoma With/Without Disulfiram and Cisplatin Navelbine
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Mar 2006
Typical duration for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 31, 2010
February 1, 2009
3.8 years
April 10, 2006
August 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumor response disease free survival survival
3 years
Secondary Outcomes (2)
Clinical response
treatment tolerance
Interventions
Eligibility Criteria
You may qualify if:
- Metastatic non-small cell lung cancer
- Previously untreated
- ECOG performance status (PS) 0-1
- Liver function tests within the norm
You may not qualify if:
- Over 18
- Willingness to abstain from alcohol
- Not pregnant
- Without a psychiatric history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hadassah Medical Organizationlead
- Augusta Hospital, Berlincollaborator
Study Sites (1)
Oncology Institute Meir Medical Center
Kfar Saba, Israel
Related Publications (2)
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.
PMID: 11774241BACKGROUNDNechushtan 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.
PMID: 25777347DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hovav Nechushtan, MD, PhD
Hadassah Medical Center Ein Kerem
- STUDY CHAIR
Nili Peylan-Ramu, MD
Hadassah Ein Kerem Medical Center
- STUDY CHAIR
Maya Gotfrid, MD
Meir Medical Center Kfar Saba
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 11, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 31, 2010
Record last verified: 2009-02