OBJECTIVES:

• Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib.
• Determine the response rate in patients with measurable disease treated with this drug.
• Determine the frequency and severity of toxic effects of this drug in these patients.
• Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug.

OUTLINE: This is a multicenter study.

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

Patients are followed every 6 months for 2 years and then annually for 1 year.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant pleural mesothelioma

  • Epithelial
  • Sarcomatous
  • Biphasic
• Measurable or nonmeasurable disease
• Not amenable to extrapleural pneumonectomy
• No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

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 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)

Renal:

• Creatinine no greater than 2 times ULN

Gastrointestinal:

• No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• No active peptic ulcer disease
• No intractable nausea or vomiting
• Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube

Ophthalmic:

• No known history of the following:

  • Dry eye syndrome
  • Sjogren's syndrome
  • Keratoconjunctivitis sicca
  • Exposure keratopathy
  • Fuch's dystrophy
  • Other active disorders of the cornea

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No HIV-positive patients receiving combination antiretroviral therapy
• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for this tumor

Chemotherapy:

• No prior chemotherapy for this tumor

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)
• Recovered from prior surgery
• No prior surgical procedures affecting absorption

Other:

• No prior investigational anticancer agents for this tumor