Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the head and neck

  * Stage III, IVA, or IVB
* Must have completed cisplatin- or carboplatin-based chemoradiotherapy within the past 4-12 weeks

  * Prior radiotherapy must have been given with a radical intent with receipt of at least 90% of planned dose
* No evidence of disease or presence of inoperable minimal residual disease, defined by 1 of the following:

  * Complete response at primary tumor site and nodes (with or without nodal surgery after chemoradiotherapy)
  * Negative lymph node status (by physical or radiological exam) AND persistent tumefaction less than 25% of original tumor size or residual mass due to scarring
* Tumor tissue samples available for EGFRvIII mutation analysis
* No known brain metastasis

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* ALT/AST \< 2 times upper limit of normal (ULN)
* Bilirubin \< ULN (unless due to Gilbert's syndrome)

Renal

* Creatinine \< 1.5 times ULN

Cardiovascular

* No myocardial infarction within the past year
* No cardiac ventricular arrhythmias requiring medication
* No history of cardiac disease
* No uncontrolled high blood pressure
* No unstable angina
* No congestive heart failure

Ophthalmic

* No history of severe dry eye syndrome, Sjögren's syndrome, or keratoconjunctivitis sicca
* No severe exposure keratopathy
* No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
* No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
* No disorder that might increase the risk for epithelium-related complication (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
* No congenital abnormality (e.g., Fuch's dystrophy)
* No ocular inflammation or infection

Gastrointestinal

* Able to take oral medication
* No gastrointestinal (GI) tract disease requiring IV alimentation
* No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
* No active peptic ulcer disease

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious active infection
* No other serious underlying medical condition that would preclude study participation
* No prior allergic reaction to compounds of similar chemical or biological composition to erlotinib
* No other malignancy with the past 5 years except adequately treated non-melanoma skin cancer (unless in the same area treated with radical radiotherapy) or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics
* Recovered from prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* Recovered from prior radiotherapy

Surgery

* See Disease Characteristics
* No prior surgical procedure affecting absorption
* No concurrent ophthalmic surgery

Other

* More than 4 weeks since other prior investigational drugs
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* Concurrent oral anticoagulants (e.g., warfarin) allowed provided there is increased vigilance with respect to INR
* Concurrent nasogastric or gastrostomy tube feeding for dysphagia allowed provided there is no evidence of significant residual mucositis (i.e., \> grade 1)