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

NCT01116336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-12-05

No results posted yet for this study

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.

Conditions

  • Cancer of Head and Neck
  • Neoplasms, 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.

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Polyphenon Pharma

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Dong M. Shin, MD · Emory University Winship Cancer Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116336 on ClinicalTrials.gov