Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following criteria:

  • Stage IIIB (with pleural effusion) or stage IV disease
  • Recurrent disease after prior surgery
• Measurable or evaluable disease is desirable but not required

• No untreated symptomatic brain metastases

  • Patients who are neurologically unstable despite radiotherapy for the brain metastases are not eligible
  • No requirement for steroids to control neurological symptoms

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• ANC ≥ 1,500/mm³
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 1.5 mg/dL
• Normal hemostasis by history
• PT/PTT within 0.5 seconds of normal range
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Willing to undergo biopsy procedures
• No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients of this product
• No other concurrent malignancies or malignancies diagnosed within the past 5 years, except basal cell carcinoma or cervical cancer in situ

• No significant cardiac disease, including any of the following:

  • NYHA class III or IV heart disease
  • Uncontrolled dysrhythmia
  • Myocardial infarction within the past 6 months

• No evidence of clinically active interstitial lung disease

  • Chronic stable radiographic changes that are asymptomatic allowed
• No evidence of any other severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial

• No uncontrolled hypertension

  • Blood pressure must be ≤ 150/90 mmHg on a stable antihypertensive regimen

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 6 months since prior adjuvant chemotherapy
• No unresolved chronic toxicity > CTC grade 2 from prior anticancer therapy (except alopecia)
• More than 30 days since prior non-approved or investigational drugs
• No prior chemotherapy for advanced NSCLC
• No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or St. John's wort
• No concurrent administration of other drugs known to inhibit EGFR
• No other concurrent anti-neoplastic or anti-tumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
• No other concurrent investigational agents
• Concurrent cardioprotective doses of aspirin, as recommended by the physician, for cardiovascular disease allowed