Spots Global Cancer Trial Database for Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck
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Trial Identification
Brief Title: Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck
Official Title: Phase I Study of Chemoprevention With Green Tea Polyphenon E (PPE) and the Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) in Patients With Premalignant Lesions of the Head and Neck
Study ID: NCT01116336
Study Description
Brief Summary: The purpose of this study is to test the preventive effects of a combination of drugs: polyphenon E (PPE) derived from green tea extracts, and erlotinib. Because this combination of drugs has not been tested in humans before for the prevention of cancer, it is not clear which dose of each agent will be optimal in combination. We will test the safety of the combination of PPE and erlotinib and see what effects (good and/or bad) it has on the patient's premalignant lesion, and find the highest dose of each agent that can be given in combination without causing severe side effects.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Contact Details
Name: Dong M. Shin, MD
Affiliation: Emory University Winship Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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