Clinical Trial Details

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Study ID IRB00014010
Dong M Shin, MD,   Emory University Winship Cancer Institute
Title Phase I Chemoprevention Trial With Green Tea Polyphenon E and Erlotinib in Patients With Premalignant Lesions of the Head and Neck
Conditions Cancer of Head and Neck
Neoplasms, Head and Neck
Interventions Drug: Erlotinib and Green Tea Polyphenon E
Phase Phase 1
Purpose 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  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
Study Location
Emory University Winship Cancer Institute
Atlanta, Georgia, 30329
Contact Dong Shin, MD
Information objtained from, on 10/24/2014. For additional information about this and other clinical trials, visit
Please refer to this study by its identifier: NCT01116336

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