Non-small Cell Lung Cancer Clinical Trial
Official title:
Randomized Phase 2 Trial of Treatment of Advanced Non Small Cell Lung Carcinoma With/Without Disulfiram and Cisplatin Navelbine
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Oncology Institute Meir Medical Center | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization | Augusta Hospital, Berlin |
Israel,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | tumor response disease free survival survival | 3 years | ||
Secondary | Clinical response | |||
Secondary | treatment tolerance |
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