Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer

Inclusion Criteria:

1. Pathologically confirmed diagnosis of recurrent or second primary squamous cell
carcinoma

2. Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx.
Recurrent neck metastasis with unknown primary is allowed

3. Prior radiation therapy for head and neck cancer

4. Disease must be considered surgically resectable or candidate for curative
reirradiation

5. Adequate diagnostic workup

6. Zubrod Performance Status 0-2

7. Life expectancy 12 weeks

8. Age 19, 9. Adequate laboratory data.

Exclusion Criteria:

1. Prior invasive cancers other than head and neck cancer unless disease free for a
minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in
situ are permissible)

2. Patients who are pregnant or lactating

3. Psychological condition that renders the patient unable to understand the informed
consent

4. Any situation or condition that will interfere with adherence to study activities.