Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck

  • All primary sites, including oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus
• Recurrent, unresectable, and/or metastatic disease

• At least 1 measurable lesion

  • At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan
• Lesions accessible for biopsy
• Tumor specimen available for evaluation of epidermal growth factor receptor (EGFR) expression
• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy:

• More than 12 weeks

Hematopoietic:

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN

Renal:

• Creatinine normal OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Gastrointestinal:

• No gastrointestinal tract disease resulting in malabsorption
• No requirement for IV alimentation
• No active peptic ulcer disease
• Inability to swallow tablets or silicon-based G-tubes allowed

Ophthalmic:

• No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjogren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
• No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except carcinoma in situ of the cervix, nonmelanoma skin cancer, or second primary squamous cell cancer originating from the head and neck
• No grade 2 or greater residual ototoxicity or neuropathy from prior platinum-based therapy
• No significant traumatic injury within the past 21 days
• No other concurrent uncontrolled illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for recurrent or metastatic disease
• Prior platinum-based chemotherapy with radiotherapy or platinum-based induction chemotherapy allowed
• At least 6 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Chemotherapy
• At least 4 weeks since prior radiotherapy (except low-dose, limited-fraction palliative non-myelosuppressive radiotherapy [e.g., involving less than 20% of functioning bone marrow using 800 cGy in 1 fraction or 2,000 cGy in 5 fractions]) and recovered
• No prior radiotherapy to target lesion unless there is evidence of disease progression

Surgery:

• See Disease Characteristics
• At least 21 days since prior major surgery
• No prior surgical procedure affecting gastrointestinal absorption

Other:

• No prior EGFR-targeting therapies
• No prior investigational agents for recurrent or metastatic disease
• No concurrent combination anti-retroviral therapy for HIV infection
• No other concurrent investigational agents
• No other concurrent anticancer treatment