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