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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving celecoxib before surgery may reduce the amount of normal tissue that needs to be removed. Collecting and storing samples of tumor tissue, blood, and urine from patients with head and neck cancer to study in the laboratory may help doctors learn more about the cancer and predict how well patients will respond to treatment with celecoxib.

PURPOSE: This phase I/II trial is studying changes in tumor cells and how well celecoxib works in treating patients with head and neck cancer that can be removed by surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Vaudois
• Treatments: Celecoxib

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