Clinical trial NCT00062101 (phase 2, status: completed)
Conditions: recurrent non-small cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: erlotinib hydrochloride, celecoxib
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C
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