Status:
UNKNOWN
Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 a...
Detailed Description
OBJECTIVES: Primary * Evaluate the changes in molecular markers of angiogenesis before and after treatment with celecoxib in tumor tissues of patients with resectable head and neck squamous cell car...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00357617
Start Date
June 1 2006
Last Update
December 24 2010
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011