Clinical trial NCT00030407 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: celecoxib, docetaxel
SMILES: COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of non-small cell lung cancer (NSCLC)

               -  Stage IIIB with pleural effusion or stage IV disease

          -  Age 70 years and over with SWOG performance status 0-2 OR age 18 to 69 with SWOG
             performance status 2

          -  Measurable or evaluable disease

          -  No symptomatic or untreated brain or leptomeningeal metastases

               -  Previously treated patients must be neurologically stable for 4 weeks after
                  completion of appropriate therapy

        PATIENT CHARACTERISTICS:

        Age:

          -  See Disease Characteristics

          -  18 and over

        Performance status:

          -  See Disease Characteristics

          -  SWOG 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 8 g/dL

        Hepatic:

          -  Bilirubin no greater than upper limit of normal (ULN)

          -  AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase
             no greater than ULN)

          -  Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no
             greater than ULN)

          -  No history of chronic hepatitis

        Renal:

          -  Creatinine no greater than 1.5 times ULN

        Cardiovascular:

          -  No uncontrolled congestive heart failure

          -  No uncontrolled angina

          -  No myocardial infarction and/or stroke within the past 6 months

          -  No active thromboembolic event within the past 4 weeks

        Gastrointestinal:

          -  No gastrointestinal bleeding within the past 6 months

          -  No history of peptic ulcer disease

        Other:

          -  No prior hypersensitivity reaction to docetaxel or other drugs formulated with
             polysorbate 80

          -  No prior allergy to any non-steroidal anti-inflammatory drug

          -  No other prior or concurrent malignancy within the past 3 years except adequately
             treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

          -  No grade 2 or greater peripheral neuropathy

          -  No other serious concurrent medical illness

          -  No history of dementia, active psychiatric disorder, or other condition that would
             interfere with ability to take oral medication or preclude compliance with study

          -  HIV negative

          -  Must weigh at least 50 kg (110 pounds)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior biologic therapy for NSCLC

        Chemotherapy:

          -  No prior chemotherapy for NSCLC

        Endocrine therapy:

          -  At least 3 days since prior steroids

        Radiotherapy:

          -  At least 4 weeks since prior radiotherapy

          -  No prior radiotherapy to target lesion

        Surgery:

          -  At least 4 weeks since prior major surgery

        Other:

          -  Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including
             rofecoxib or celecoxib, allowed

          -  At least 1 week since prior fluconazole

          -  No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than
             30 consecutive days

          -  No concurrent fluconazole or lithium

          -  No concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day
             for cardiovascular conditions

          -  No other concurrent cyclo-oxygenase-2 inhibitors

          -  No other concurrent investigational agents