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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT01116336
Phase
PHASE1
Status
Completed

Conditions

  • Cancer of Head and Neck
  • Neoplasms, Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    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).
  • Green Tea Polyphenon E — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

First listed
May 5, 2010
Start date
Mar 31, 2010
Status verified
Dec 2018
Primary completion
May 31, 2018
Completion
May 31, 2018

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Erlotinib and Green Tea Polyphenon E
    Patients will receive erlotinib, at pre-defined dose level, with polyphenon E.

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-

Find similar trials in Atlanta, GA

By research site
Emory University Hospital Midtown· Atlanta, GAEmory University Winship Cancer Institute· Atlanta, GAJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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