Laboratory Test in Predicting Response to Erlotinib in Patients With Relapsed Metastatic or Unresectable Non-Small Cell Lung Cancer That Did Not Respond to Previous Treatment

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic or unresectable non-small cell lung cancer

• Relapsed disease

  • Failed ≥ 1 prior chemotherapy regimen
• Measurable disease
• Tumor must be accessible to fine-needle aspiration

• No uncontrolled brain metastases

  • Patients with brain metastases must have stable neurologic status after local therapy (surgery or radiotherapy) for ≥ 4 weeks and no neurologic dysfunction that would preclude evaluation of neurologic and other adverse events

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy > 12 weeks
• WBC > 3,000/mm³
• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³
• Bilirubin normal
• PT and activated PTT normal
• Creatinine normal OR creatinine clearance > 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• No uncontrolled intercurrent illness, including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situation that would preclude study compliance

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

  • Severe dry eye syndrome
  • Keratoconjunctivitis sicca
  • Sjögren's syndrome
  • Severe exposure keratopathy
  • Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
• No serious, nonhealing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 14 days NOTE: *Patients with mild forms of any of the above ophthalmologic abnormalities, an asymptomatic history, or a normal ophthalmologic examination allowed at the discretion of the investigator. Patients with treatable conditions (e.g., infectious keratitis/conjunctivitis or allergic conjunctivitis) allowed after treatment or resolution of the condition.

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior small molecule inhibitors of epidermal growth factor receptor, including erlotinib hydrochloride or gefitinib
• At least 4 weeks since prior anticancer therapy, including chemotherapy, radiotherapy, biologic therapy, or other investigational therapy (6 weeks for nitrosoureas or mitomycin C)
• More than 14 days since prior major surgery or open biopsy and recovered

• At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following:

  • Itraconazole

  • Herbal extracts and tinctures, including any of the following:

    • Hydrastis canadensis (goldenseal)
    • Uncaria tomentosa (cat's claw)
    • Echinacea angustifolia roots
    • Trifolium pratense (wild cherry)
    • Chamomile
    • Licorice root
    • Dillapiol
    • Naringenin

• No concurrent inducers of CYP3A4, including any of the following:

  • Phenytoin
  • Carbamazepine
  • Rifampin
  • Barbiturates
  • Hypericum perforatum (St. John's wort)
• No concurrent chemotherapy
• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent radiotherapy, including palliative radiotherapy
• No concurrent therapeutic anticoagulation
• No other concurrent anticancer agents or therapies