• Correlation of the CA dinucleotide repeat polymorphism in the epidermal growth factor receptor (EGFR) gene with toxicity
• Pharmacodynamic effects

• Antitumor response
• Toxicity

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase I/II trial is studying the side effects of erlotinib and to see how well it works in treating patients with metastatic or unresectable non-small cell lung cancer, ovarian cancer, or squamous cell carcinoma (cancer) of the head and neck.

OBJECTIVES:

• Correlate the length of the CA dinucleotide repeat polymorphism in the epidermal growth factor receptor (EGFR) gene with observed toxicity in patients with advanced non-small cell lung cancer, ovarian cancer, or squamous cell carcinoma of the head and neck treated with erlotinib.
• Determine the pharmacodynamic effects of this drug on EGFR activity and MAP kinase signaling in these patients.
• Correlate toxicity and inhibition of EGFR phosphorylation with the area under the curve in patients treated with this drug.
• Determine the observed antitumor response in patients treated with this drug.
• Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to length of CA dinucleotide repeat polymorphism (short vs medium vs long).

Patients receive oral erlotinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 20 months.

• Drug/Agent Toxicity by Tissue/Organ
• Head and Neck Cancer
• Lung Cancer
• Ovarian Cancer

DISEASE CHARACTERISTICS:

• One of the following histologically or cytologically confirmed malignancies:

  • Non-small cell lung cancer
  • Ovarian cancer
  • Squamous cell carcinoma of the head and neck
• Metastatic or unresectable disease
• Measurable or evaluable disease

• No uncontrolled brain metastases

  • Previously treated brain metastases allowed provided neurologic status has been stable for at least 4 weeks after therapy and there is no neurologic dysfunction that would confound evaluation of adverse events

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 normal

Renal

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

Cardiovascular

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

Ophthalmic

• No significant ophthalmologic abnormalities*, including any of the following:

  • Severe dry eye syndrome
  • Keratoconjunctivitis sicca
  • Sjögren's syndrome
  • Severe exposure keratopathy

  • Disorders that increase the risk for epithelium-related complications, including any of the following:

    • Bullous keratopathy
    • Aniridia
    • Severe chemical burns
    • Neutrophilic keratitis NOTE: *Patients with mild forms of the listed conditions, an asymptomatic history, or normal ophthalmologic exam may be eligible at the discretion of the investigator

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to erlotinib
• No significant traumatic injury within the past 14 days
• No other uncontrolled illness that would preclude study participation
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No serious nonhealing wound ulcer or bone fracture

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 4 weeks since prior biologic therapy

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• More than 14 days since prior major surgery or open biopsy

Other

• Recovered from all prior therapy
• At least 4 weeks since other prior investigational therapy
• No prior small molecule epidermal growth factor receptor inhibitors, including erlotinib and gefitinib
• No other concurrent therapy for the malignancy
• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients