Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery

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