Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
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
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Experimental
Celecoxib & Docetaxel
Celecoxib: On day -7 of the first cycle, patients will start, Celecoxib 400 mg po bid daily, each dose to give with meals Docetaxel: On day 1, 8, and 15 of each cycle patients will receive: Docetaxel 36mg/m2 over 60 minutes, duration of each cycle will be 28 days.