Phase I Chemoprevention Trial With Green Tea Polyphenon E & Erlotinib in Patients With Premalignant Lesions of the Head & Neck
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|ClinicalTrials.gov Identifier: NCT01116336|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2010
Last Update Posted : December 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Head and Neck Neoplasms, Head and Neck||Drug: Erlotinib Dietary Supplement: Green Tea Polyphenon E||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Chemoprevention With Green Tea Polyphenon E (PPE) and the Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) in Patients With Premalignant Lesions of the Head and Neck|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2019|
Experimental: Erlotinib and Green Tea Polyphenon E
Patients will receive erlotinib, at pre-defined dose level, with polyphenon E.
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).
Other Names: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.
Other Name: EGCG
- 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 ]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.
- 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. [ Time Frame: Baseline, 3, 6, and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116336
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Dong M. Shin, MD||Emory University Winship Cancer Institute|