Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria:

* Histologically or cytologically confirmed, previously untreated HNSCC.
* Clinical stage II, III or IVA disease without distant metastasis, as defined by the American Joint Committee on Cancer Staging System, Sixth edition (See Appendix I).
* Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx will be included. Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors are NOT allowed.
* Macroscopic complete resection of the primary tumor must be planned.
* Patients will be willing to receive postoperative therapy with platinum and radiation if qualified based on criteria listed in treatment plan.
* Age 18 years.
* ECOG performance status 0-1 (See Appendix II).
* Adequate hematologic, renal and hepatic function, as defined by:

  * Absolute neutrophil count (ANC) greater than 1,500/ul, platelets greater than 100,000/ul.
  * Creatinine less than 1.5 x institutional upper limit of normal (ULN).
  * Bilirubin less than 1.5 x ULN, AST or ALT 2.5 x ULN.
* Have signed written informed consent.

Exclusion Criteria:

* Subjects who fail to meet the above criteria.
* Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy.
* Subjects with a ECOG performance status of 2 or worse.
* Evidence of distant metastasis.
* Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast.
* Prior history of HNSCC.
* Prior therapy targeting the EGFR pathway.
* Known severe hypersensitivity to sulindac or other non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin.
* Any unresolved chronic toxicity greater than grade 2 from previous anticancer therapy (except alopecia), according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
* Incomplete healing from previous major surgery.
* Acute hepatitis, known HIV, or active uncontrolled infection.
* History of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months, untreated known coronary artery disease, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
* Any preexisting active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic are NOT excluded).
* Treatment with anticoagulants, except when used to maintain the patency of a central venous line.
* Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months.
* Active alcohol abuse or other illness that carries a likelihood of inability to comply with study treatment and follow-up.
* Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.