Phase II Study to Evaluate the Tumor Biochemical Effects of the EGFR Tyrosine Kinase Inhibitor OSI-774 (Erlotinib) Administered Prior to Surgical Resection in Patients With Early Stage Non-Small Cell Lung Cancer

Date de début de l'étude : 1 décembre 2004

Inclusion Criteria: * Patients with suspicion of lung cancer without distant metastases * Patients are scheduled to have a tissue diagnostic procedure within 3 to 5 days of pre-registration * Patients are willing to allow collection and submission of baseline and post-therapy tumor tissue, skin and blood samples for this study * Patients must have ECOG performance status of 0, 1, or 2 * Patients must have no psychological, familial, sociological, or geographic conditions that will interfere with medical follow-up and compliance with the study protocol * Patients must have no prior chemotherapy or radiation therapy or no prior anti- EGFR treatment exposure * Patients must be able to take oral medication and not have malabsorption syndrome, or prior gastrointestinal surgery that limits their absorption (i.e. requiring total parental nutrition) * Patients must not be using phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, oxcarbazepine, rifapentine, St John's Wort, or any other CYP 3A4 enzyme-inducing agent; any use of these substances must be discontinued at least 2 weeks prior to registration * Patients must not be taking any anti-coagulants * Patients must not have been treated with a non-approved or investigational drug within 21 days prior to pre-registration; patients must not have serious underlying medical condition that would impair the ability of patient to receive the planned treatment * Patients with a known hypersensitivity to OSI-774 (erlotinib) are not eligible * Patients must have histologically confirmed NSCLC; cytologic specimens obtained by brushing, washing or needle aspiration of defined lesions will be acceptable * Patients must have stage IA (T1N0M0), stage IB (T2N0M0), stage IIA (T1N1M0), stage IIB (T2N1M0; T3N0-1M0), or stage IIIA (T1-3N2M0) disease * Patients with small cell component on histology specimen are not eligible * A paraffin-embedded cell block and 1-2 segments of frozen tissue demonstrating NSCLC and obtained during the diagnostic biopsy is available for submission * Patients must be considered operable candidates and disease must be considered resectable * Pregnant or breastfeeding women are excluded from the study because the agents used in this study may be teratogenic to a fetus or child and there is no information on the excretion of the agents or their metabolites into breast milk * All females of childbearing potential must have a blood test or urine study within 1 week, prior to registration to rule out pregnancy * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception * WBC \>= 3500/mm\^3 * ANC \>= 1500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Total bilirubin \< 1.5mg/dL * SGPT and SGOT \< 3 times institution's upper limit of normal * Serum creatinine \< 2mg/dl or creatinine clearance \>= 20 ml/min