Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
Head and Neck Cancer, Lung Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage I non-small cell lung cancer, stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, salivary gland squamous cell carcinoma, stage I salivary gland cancer, stage II salivary gland cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: One of the following histologically confirmed diagnoses: Stage I non-small cell lung cancer (NSCLC) No small cell component Stage I-II squamous cell cancer of the head and neck No WHO type II or III nasopharyngeal cancer No sinonasal undifferentiated carcinoma No evidence of disease Must have undergone surgery or radiotherapy with curative intent within the past 4-24 weeks PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Platelet count at least 50,000/mm^3 Hepatic Bilirubin normal AST/ALT no greater than 2 times upper limit of normal Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No uncontrolled hypertension No severe congestive heart failure Pulmonary No history of asthma caused by cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No other prior malignancy (including skin cancer and in situ malignancies) No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days No prior hypersensitivity reaction to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides No other concurrent medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy No cumulative oral or IV corticosteroid use totalling more than 2 weeks within the past 3 months No concurrent oral steroids for more than 2 consecutive weeks Concurrent inhaled steroids allowed Radiotherapy See Disease Characteristics No prior definitive radiotherapy for stage I NSCLC Surgery See Disease Characteristics Prior pneumonectomy or lobectomy with mediastinal lymph node sampling or dissection for stage I NSCLC allowed No prior segmentectomies or wedge resections for stage I NSCLC Other More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis No prior NSAID use within the past 30 days at a frequency of 3 or more times a week for more than 2 weeks No concurrent NSAIDs (including low-dose aspirin) No other concurrent COX-2 inhibitors No concurrent fluconazole No concurrent lithium
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Rush Cancer Institute at Rush University Medical Center
- University of Chicago Cancer Research Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill