Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2

This is a phase I study of second primary tumor prevention in early stage (stage I/II)
patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).

The study will evaluate the effect on cells and clinical response to study medications:
Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774,
Tarceva™), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib). The side effects of the
medications will be assessed, and chemicals in the cells will be evaluated both before and
after medication is administered that may show how the drugs work. This information will help
researchers determine whether additional studies with these drugs should be conducted to
determine if the drugs can help prevent pre-cancerous lesions from becoming cancerous.

SCCHN accounts for 5% of all cancer, and there is an incidence of approximately 37,200 new
cases in the United States per year with 11,000 deaths. The five-year survival rate for
patients with SCCHN in the United States and other developed countries is still poor,
approximately 40%, comparable to the five-year survival rate in the 1970s despite advances in
detection, surgery, radiation, and chemotherapy. Thus, a preventative approach before the
development of invasive cancer or second primary tumors (SPTs) is highly desirable and novel
strategies to reduce cancer incidence in SCCHN and other tobacco-carcinogen related
malignancies are being pursued.

Inclusion Criteria:

- Patients must have, or have previously had, stage I (T1NO) or stage II (T2NO) squamous
cell carcinoma of the head and neck.

- Tumor 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.

- May have oral pre-malignant lesions (i.e., hyperplasia, dysplasia, carcinoma in situ)
provided their Stage I or II disease has been definitively treated.

- Must have been free of disease for a minimum period of 8 weeks up to maximum of 3
years following completion of surgery and/or radiotherapy.

- Must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of
0-1.

- Patients must be 18 years of age or greater.

- Female patients of childbearing potential must practice adequate contraception and
have a negative pregnancy test (β-HCG).

- Must be able to swallow the Erlotinib and Celecoxib pills.

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.

Exclusion Criteria:

- Acute intercurrent illness or those who had surgery within the preceding 4 weeks
unless they have fully recovered.

- History of previous malignancies other than squamous cell carcinoma of the head and
neck unless the cancer was non-melanoma skin cancer.

- Participants who are pregnant or breast feeding.

- Documented history of coagulopathy and/or those taking warfarin or warfarin-derivative
anticoagulants within 6 months of entry into the study.

- Hypertension not adequately controlled by medication as shown by a systolic ≥180 @
screening.

- Documented history of interstitial lung disease.

- Known connective tissue disease.

- Participated in a clinical trial of an investigational drug within 12 months prior to
enrollment.

- Any active cardiovascular events including angina, unstable angina, palpitation,
tachycardia, arrhythmia, or participant has had a recent cerebrovascular accident
(stroke) or Myocardial Infarction (< 6 months).

- Any history of clinically significant ventricular arrythmias (such as ventricular
tachycardia, ventricular fibrillation, or Torsades de Pointes).

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.