NCT01116336 - Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions

Cancer of Head and NeckNeoplasms, Head and Neck

Interventions

DRUG

Erlotinib

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).

DIETARY_SUPPLEMENT

Green Tea Polyphenon E

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.

Trial Locations (3)

21287

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Winship Cancer Institute, Atlanta