Overview

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

Status:
Completed

Trial end date:
2018-05-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Emory University

Collaborators:

Astellas Pharma Inc
National Cancer Institute (NCI)
Polyphenon Pharma

Treatments:

Erlotinib Hydrochloride