Phase I Study of Erlotinib and Celecoxib in Former Smokers With Advanced Non-Small Cell Lung Cancer

Date de début de l'étude : 1 décembre 2003

Criteria: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria: Stage IIIB with pleural effusion; Stage IV disease; recurrent or progressive disease after prior surgery, radiotherapy, and/or chemotherapy * If the sole prior treatment was in the adjuvant or neoadjuvant setting, tumor progression or recurrence must have occurred within 6 months after completion of prior treatment * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL * Hemostasis normal * Creatinine =\< 2.0 mg/dL * No significant cardiovascular disease * No New York Heart Association class III or IV cardiac disease * No uncontrolled dysrhythmia * No unstable angina * No myocardial infarction within the past 6 months * FEV1 \>= 1.0 liter OR 40% of predicted within the past 3 months * Oxygen saturation \>= 90% on room air * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study treatment * Willing to undergo bronchoscopy * No allergy to sulfonamides or hypersensitivity reaction to celecoxib * No other medical or psychological condition (e.g., acute psychosis) that would preclude study participation * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin) * At least 4 weeks since prior radiotherapy * Prior complete resection allowed provided there is histologic and cytologic documentation of disease recurrence * More than 3 months since prior chemopreventative agents (e.g., oltipraz, retinoids, or N-acetylcysteine \[NAC\]) * No prior erlotinib hydrochloride * No other prior EGFR antagonists * No concurrent medication known to interact with erlotinib hydrochloride or celecoxib, including the following: Fluconazole, Lithium, Furosemide, Angiotensin-converting enzyme inhibitors, Phenytoin, Carbamazepine, Rifampin, Barbiturates, Hypericum perforatum (St. John's wort) * No concurrent non-steroidal anti-inflammatory drugs * Concurrent aspirin of up to an average dose of 325 mg/day allowed * No aspirin treatment for 7 days prior to any bronchoscopic or skin biopsy * No other concurrent EGFR inhibitors or cyclo-oxygenase-2 (COX-2) inhibitors * Meets 1 of the following criteria: 1) Advanced NSCLC with at least stable disease after \>= 4 courses of platinum-containing chemotherapy 2) Relapsed or refractory disease after treatment with \>= 1 prior platinum-containing chemotherapy program, including adjuvant or neoadjuvant therapy for NSCLC * No untreated brain metastases * ECOG 0-1 * Former smoker, as indicated by the following: 1) At least a 30 pack-year smoking history 2) Smoking duration at least 10 years 3) At least 12 months of self-reported smoking cessation 4) Negative urine cotinine