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Tyrosine Kinase Inhibitors

Erlotinib Hydrochloride

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Tyrosine

Patients will receive erlotinib, at pre-defined dose level, with polyphenon E.

Participants will be given erlotinib orally (dose escalation from 50 mg, 75 mg, or 100 mg daily continuously for 6 cycles (each cycle is 28 days).

Erlotinib

Participants will also be given PPE orally (200 mg EGCG) three times daily for 6 cycles (each cycle is 28 days). PPE capsules will be taken on a full stomach, within one hour after eating a substantial meal.

Green Tea Polyphenon E

Dong M. Shin, MD

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.

Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck

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

Define MTD as the dose level of erlotinib when administered with a constant dose of 200 mg (EGCG) TID of Green Tea Polyphenon E (PPE) to a patient results in a probability equal to θ = 0.33 that a dose-limiting toxicity (DLT) will be manifest within 1 cycle defined as 28 days.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck	NCT01116336	Cancer of Head ... Neoplasms, Head...	Erlotinib Green Tea Polyp...	18 Years -	Emory University
Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck	NCT01116336	Cancer of Head ... Neoplasms, Head...	Erlotinib Green Tea Polyp...	18 Years -	Emory University

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