Gefitinib and Celecoxib in Treating Patients With Refractory Non-Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• •Progression of disease during platinum-based (cisplatin or carboplatin) chemotherapy or within 3 months of completing chemotherapy
• •* Treatment with other agents since prior platinum-based chemotherapy allowed
• •Measurable disease
• •* Target lesions within a prior radiation field must have documented evidence of progression at least 8 weeks after the completion of radiotherapy
• •No active brain or leptomeningeal metastases
• •* Treated brain metastases allowed at least 4 weeks after the completion of appropriate therapy
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 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 2.5 times ULN (if alkaline phosphatase is no greater than ULN)
• •Alkaline phosphatase no greater than 5 times ULN (if AST and ALT are greater than ULN)
• •No history of chronic hepatitis
• •Renal
• •Creatinine no greater than 1.5 times ULN
• •Cardiovascular
• •No active thromboembolic event within the past 4 weeks
• •No uncontrolled congestive heart failure
• •No uncontrolled angina
• •No myocardial infarction and/or stroke within the past 6 months
• •Pulmonary
• •No evidence of clinically active interstitial lung disease
• •Gastrointestinal
• •No history of gastrointestinal bleeding within the past 6 months
• •No history of peptic ulcer disease
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Must weigh at least 110 pounds (50 kg)
• •HIV negative
• •No allergy to sulfonamides
• •No allergy to any NSAID, including celecoxib
• •No known severe hypersensitivity to gefitinib or any of its excipients
• •No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• •No history of dementia, active psychiatric disorder, or any other condition that would preclude study compliance
• •No other concurrent serious medical condition
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior epidermal growth factor receptor inhibitor
• •No concurrent biologic therapy
• •Chemotherapy
• •See Disease Characteristics
• •More than 2 weeks since prior chemotherapy
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •Recovered from prior radiotherapy
• •Surgery
• •Recovered from prior surgery
• •Other
• •Recovered from prior therapy
• •More than 2 weeks since prior investigational therapy
• •More than 1 week since prior fluconazole
• •More than 30 days since prior participation in another investigational agent clinical trial
• •More than 30 days since prior chronic nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib or rofecoxib
• •No prior gefitinib
• •No prior cyclooxygenase-2 (COX-2) inhibitor or another clinical trial for NSCLC
• •No other concurrent NSAIDs
• •* Concurrent aspirin allowed (not to exceed 325 mg/day)
• •No other concurrent COX-2 inhibitors
• •No concurrent lithium
• •No concurrent fluconazole
• •No concurrent use of any of the following:
• •* Phenytoin
• •* Carbamazepine
• •* Barbiturates
• •* Rifampin
• •* Phenobarbital
• •* Hypericum perforatum