Celecoxib and Erlotinib in Treating Former Smokers With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.