Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent 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
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer Stage IIIB (malignant pleural effusion only) or IV Recurrent disease that has progressed after 1 or 2 prior chemotherapy regimens (platinum- or nonplatinum-based) At least 1 unidimensionally measurable lesion* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Must have tissue specimen available for assays No brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 3 months WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin normal AST/ALT no greater than 2.5 times upper normal limit (ULN) Creatinine normal Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No prior abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) No congenital abnormality (e.g., Fuch's dystrophy) No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Able to ingest oral medication No requirement for IV alimentation No history of peptic ulcer disease No active gastrointestinal ulcers Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent uncontrolled illness No ongoing or active infection No significant traumatic injury within the past 21 days No psychiatric illness or social situation that would preclude study compliance No prior allergic reactions to sulfonamides, aspirin, and other nonsteroidal anti-inflammatory drugs No prior monoclonal antibodies to epidermal growth factor receptor (EGFR) More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No concurrent chemotherapy No concurrent glucocorticoids More than 4 weeks since prior radiotherapy and recovered More than 21 days since prior major surgery No prior surgery affecting absorption No prior EGFR-specific tyrosine kinases No concurrent anticonvulsants No other concurrent investigational agents No concurrent antiretroviral therapy for HIV-positive patients No concurrent antacids No concurrent administration of any of the following drugs: Amiodarone Chloramphenicol Cimetidine Fluvoxamine Omeprazole Zafirlukast Clopidogrel Cotrimoxazole Disulfiram Fluconazole Fluoxetine Fluvastatin Fluvoxamine Isoniazid Itraconazole Ketoconazole Leflunomide Metronidazole Modafinil Paroxetine Phenylbutazone Sertraline Ticlopidine Valproic acid
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group I (erlotinib hydrochloride, celecoxib)
Group II (erlotinib hydrochloride)
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
Patients receive erlotinib as in group 1.