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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Astellas Pharma Inc
Polyphenon Pharma
Information provided by (Responsible Party):
Dong Shin, Emory University Identifier:
First received: April 9, 2010
Last updated: June 11, 2014
Last verified: June 2014

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 Intervention Phase
Cancer of Head and Neck
Neoplasms, Head and Neck
Drug: Erlotinib and Green Tea Polyphenon E
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Chemoprevention Study With Green Tea and Erlotinib in Patients With Premalignant Lesions of the Head and Neck

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Define MTD as the dose level of erlotinib when administered with a constant dose of 200mg (EGCG) TID of Green Tea Polyphenon E (PPE) to a patient results in a probability equal to θ = 0.33 that a DLT will be manifest within 1 cycle defined as 30 days. [ Time Frame: Cytobrush/biopsy at three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety of the combination of PPE and erlotinib in patients receiving 3 different doses of erlotinib (50mg, 75mg, and 100mg) in combination with PPE (200mg EGCG TID) for 6 months. [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 (Treatment)
Patients will receive erlotinib, at pre-defined dose level (described above), with polyphenon E.
Drug: Erlotinib and Green Tea Polyphenon E
Participants will be given erlotinib orally (dose escalation from 50mg, 75mg, or 100mg daily continuously for 6 cycles (each cycle is 30 days). Participants will also be given PPE orally (200mg EGCG) three times daily for 6 cycles (each cycle is 30 days). PPE capsules will be taken on a full stomach, within one hour after eating a substantial meal.
Other Names:
  • Erlotinib
  • OSI-774
  • Tarceva
  • Green Tea Polyphenon E
  • EGCG


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Have premalignant lesions (mild dysplasia, moderate dysplasia, severe dysplasia, or carcinoma in situ) of the head and neck, confirmed by biopsy within the 3 months prior to study entry
  2. Lesion sites include oral cavity (buccal mucosal, gingival, floor of mouth, dorsal/ventral tongue, pharyngeal wall), oropharynx, hypopharynx, and larynx (glottis, supraglottis, subglottis, epiglottis)
  3. ECOG/Zubrod performance status of 0-1
  4. Age ≥ 18 years old
  5. No medical contraindications for flexible laryngoscopy using topical anesthesia, and in the setting of a contraindication to topical anesthesia, general anesthesia may not be used as a substitute.
  6. General anesthesia is acceptable in patients whose lesions would require general anesthesia for laryngoscopy and biopsy according to routine standard of care
  7. Total neutrophil count >1,500/mm3; platelet count >100,000/mm3
  8. Adequate liver function: total bilirubin level <2.0 mg/dl; albumin >2.5 g/dl; transaminase (AST and ALT) ≤ upper normal limit (ULN)
  9. Adequate renal function: serum creatinine <1.5 mg/dl
  10. Hemoglobin level ≥ 11gm/dl (age adjusted if appropriate) provided by the reference laboratory (RL) performing the test
  11. Patients not taking warfarin must have PT/PTT levels ≤ 1.5 times the ULN provided by RL performing test
  12. Adequate pulmonary function: FEV1 and FVC at least 60% predicted value by spirometry
  13. Participants must have a signed written informed consent
  14. Polyphenon E may be teratogenic, so women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
  15. Women of child-bearing potential must also have a negative urine pregnancy test (β-HCG) within 72 hours of receiving treatment.
  16. Ability to swallow oral doses of erlotinib and PPE
  17. Willing to abstain from drinking green tea or taking supplements containing green tea or green tea compounds, for the duration of the investigation and for 30 days prior to study entry

Exclusion Criteria

  1. Participants <18 years of age children are excluded
  2. Participants with hyperplasia will be excluded because there is possibly no benefit.
  3. Acute intercurrent illness or those who had surgery within the preceding 4 weeks unless fully recovered
  4. Previous malignancies unless the cancer was stage I or II and rendered free of disease more than 1 year
  5. Participants who are pregnant or breast feeding. Polyphenon E is an Investigational agent with teratogenic or abortifacient potential. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Polyphenon E, so breastfeeding should be discontinued if the mother is treated with Polyphenon E
  6. Patients who are not practicing adequate contraception if the participants are of child bearing potential
  7. History of cardiovascular events including angina, unstable angina, arrhythmia, in addition to recent myocardial infarction (<6 months), or history of cerebrovascular disease
  8. Uncontrolled intercurrent illness not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  9. Documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants
  10. Hypertension not adequately controlled by medication
  11. Documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) Grade II
  12. Participants who exhibit confusion, disorientation, or have a history of major psychiatric illness which may impair their understanding of the informed consent
  13. Use of EGFR tyrosine kinase inhibitors within 3 months of study entry
  14. Documented history of interstitial lung disease
  15. Known connective tissue disease
  16. Participation in clinical trial of an investigational drug within 12 months prior to enrollment
  17. History of liver disease or elevated AST/ALT on screening
  18. Consumption of green tea/supplements containing green tea/tea extract within 30 days prior to enrollment
  19. Allergy to compounds of similar chemical or biologic composition to polyphenon E, tea, or any of the inactive ingredients present in the drug products including gelatin capsules
  20. Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01116336

United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30329
Contact: Dong Shin, MD    888-946-7447   
Principal Investigator: Dong Shin, MD         
Sponsors and Collaborators
Emory University
Astellas Pharma Inc
Polyphenon Pharma
Principal Investigator: Dong M Shin, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Dong Shin, Principal Investigator, Emory University Identifier: NCT01116336     History of Changes
Other Study ID Numbers: IRB00014010, WCI1549-08
Study First Received: April 9, 2010
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Pre-cancerous conditions
Head and neck tumors
Cancer of head and neck

Additional relevant MeSH terms:
Head and Neck Neoplasms
Precancerous Conditions
Neoplasms by Site
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors processed this record on November 25, 2014