Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer

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