Defined Green Tea Catechin Extract and Erlotinib Hydrochloride in Treating Patients with Premalignant Lesions or Previously Treated Early Stage Squamous Cell Cancer of the Head and Neck

Inclusion Criteria

• TREATMENT GROUP
• Participants with premalignant lesions (mild dysplasia, moderate dysplasia, severe dysplasia, or carcinoma in situ) of the head and neck, as confirmed by biopsy within the 4 months prior to study entry or a treated primary T1N0 or T2N0 squamous cell carcinoma will be eligible
• For patients with T1N0 or T2N0 treated squamous cell carcinoma they must have been free of disease for a minimum period of 8 weeks, up to a maximum of 3 years following completion of surgery and/or radiotherapy
• Eligible tumor and premalignant lesion sites include oral cavity (buccal mucosal, gingival, floor of mouth, dorsal/ventral tongue, pharyngeal wall), oropharynx, larynx (glottis, supraglottis, subglottis, epiglottis), hypopharynx paranasal sinus and nasal cavity
• Patients with a treated T1N0 or T2N0 squamous cell carcinoma may have oral premalignant lesions (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry (provided their stage I or II disease has been definitively treated)
• Lesion sites include oral cavity (buccal mucosa, gingival, floor of mouth, dorsal/ventral tongue, pharyngeal wall), oropharynx, hypopharynx, larynx (glottis, supraglottis, subglottis, epiglottis), nasopharynx and paranasal sinuses
• Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1
• Participants must have 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
• General anesthesia, if indicated, is acceptable in patients whose lesions would require general anesthesia for laryngoscopy and biopsy according to routine standard of care
• Total neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3
• Total bilirubin level =< 1.5 times upper limit of normal (ULN)
• Albumin > 2.5 g/dl
• Alkaline phosphatase =< 2.5 time ULN
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times ULN
• Serum creatinine < 1.5 mg/dl
• Patients must have hemoglobin level >= 11gm/dl (age adjusted if appropriate) provided by the reference laboratory performing the test
• Patients not taking warfarin must have prothrombin time (PT)/partial thromboplastin time (PTT) levels =< 1.5 times the upper limit of normal provided by the reference laboratory performing the test
• Patients must have adequate pulmonary function: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at least 60% predicted value by spirometry
• Participants must have a signed written informed consent
• 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
• Women of child-bearing potential must also have a negative urine pregnancy test (beta-human chorionic gonadotropin [HCG]) within 72 hours of receiving treatment
• Participants must be able to swallow the oral doses of erlotinib and PPE
• Participants must be 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 * (Please note that patients with a treated T1N0 or T2N0 squamous carcinoma and who do not have a pre-malignant measurable lesion at the time of study entry will not be subjected to a biopsy but will have cytobrush samples taken as specified in the protocol)
• CONTROL GROUP
• Participants in the control group must be disease free, never-smokers and otherwise healthy

Exclusion Criteria

• TREATMENT GROUP
• Participants with hyperplasia, in absence of dysplasia or carcinoma in situ, will be excluded
• Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered
• History of previous malignancies unless the cancer was stage I or II and rendered free of disease more than 1 year
• Participants who are pregnant or breast feeding; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with Polyphenon E
• Patients who are not practicing adequate contraception if the participants are of child bearing potential
• Patients with uncontrolled intercurrent illness including, but not limited to, severe active infection, symptomatic congestive heart failure, myocardial infarction within the past six months, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are excluded
• Patients with a documented history of coagulopathy such as hemophilia or von Willebrand’s disease or inherited thrombophilia
• Patients with hypertension not adequately controlled by medication (i.e. systolic blood pressure >= 150 and/or diastolic blood pressure >= 90 on at least two separate readings)
• Patients with a documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) grade II
• Participants who exhibit confusion, disorientation, or have a history of major psychiatric illness which may impair their understanding of the informed consent
• Participants who were taking EGFR tyrosine kinase inhibitors within 3 months of study entry
• Patients with a documented history of interstitial lung disease or pulmonary fibrosis
• Patients with a known connective tissue disease
• Patients who have participated in a clinical trial of an investigational drug within 12 months prior to enrollment
• Patients with a history of liver disease or AST/ALT >= 2.5 times ULN on screening
• Consumption of green tea or supplements containing green tea or tea extract within 30 days prior to enrollment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Polyphenon E, tea, or any of the inactive ingredients present in the active or placebo drug products, including gelatin capsules
• Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study