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

Inclusion 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