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

Inclusion Criteria

• •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