Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed or high clinical suspicion of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx No carcinoma of sinonasal or nasopharynx Clinical stage T1-4, N0-2, M0 disease Tumor must be considered resectable with planned surgical excision No lymph nodes > 6 cm (N3) No distant metastasis PATIENT CHARACTERISTICS: Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL Creatinine ≤ 1.5 times upper limit of normal (ULN) Creatinine clearance ≥ 60 mL/min AST and ALT ≤ 2.5 times ULN Bilirubin normal History of prior malignancy allowed if there is no evidence of recurrence or metastases at the time of screening No comorbidity that precludes operability No known liver impairment Known recent gastric or duodenal ulcer allowed if treated for > 6 weeks prior to study enrollment No known hypersensitivity to celecoxib No known allergic reactions to sulfonamides, aspirin, or other NSAIDs No psychological, familial, sociological, or geographical condition that would interfere with study compliance and follow-up schedule Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: More than 2 months since prior and no other concurrent anticancer or investigational drugs More than 2 weeks since prior and no other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids No prior radiotherapy to the head and neck region No concurrent radiotherapy No concurrent therapeutic anticoagulation No concurrent administration of any of the following: Other cyclooxygenase-2 inhibitors Aspirin Low-dose aspirin for cardiovascular prophylaxis allowed Aluminum and magnesium-containing antacids ACE inhibitors Furosemide Known inhibitors of P450 2C9 (e.g., fluconazole, fluoxetine, fluvoxamin, isoniazid, omeprazole) Known inducers of P450 2C9 (e.g., rifampin) Lithium Acenocoumarol
Sites / Locations
- Centre Hospitalier Universitaire Vaudois