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

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer
Eligibility 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
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Experimental
Celecoxib & ZD1839
Celecoxib: 400mg orally two times a day, taken with meals. ZD1839: 250 mg po every day, taken with or without food.