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

Phase 1

Completed

• Conditions: Cancer of Head and Neck; Neoplasms, Head and Neck
• Interventions: Drug: Erlotinib; Dietary Supplement: Green Tea Polyphenon E

• Registration Number: NCT01116336
• Lead Sponsor: Emory University

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

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erlotinib and Green Tea Polyphenon E	Erlotinib	Patients will receive erlotinib, at pre-defined dose level, with polyphenon E.
Erlotinib and Green Tea Polyphenon E	Green Tea Polyphenon E	Patients will receive erlotinib, at pre-defined dose level, with polyphenon E.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of erlotinib when administered with a constant dose of green tea polyphenon E (PPE).	Cytobrush/biopsy at three months	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.

Secondary Outcome Measures

Name	Time	Method
To assess the safety of the combination of PPE and erlotinib in patients receiving 3 different doses of erlotinib (50 mg, 75 mg, and 100 mg) in combination with PPE (200 mg EGCG TID) for 6 months.	Baseline, 3, 6, and 12 months

Trial Locations

Locations (3)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Emory University Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States