Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery
NCT ID: NCT00357617
Last Updated: 2010-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2006-06-30
Brief Summary
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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.
Detailed Description
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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 carcinoma.
Secondary
* Evaluate the changes in molecular markers of angiogenesis before and after treatment with celecoxib in blood tissues of these patients.
* Evaluate the effects of celecoxib on indirect measures of tumor perfusion, as measured by perfusion CT scan, in these patients.
* Evaluate the effects of celecoxib on apoptosis and proliferation rate on tumor cells and on endothelial cells in these patients.
* Identify potential new markers of the activity of cyclooxygenase-2 inhibitors and identify new pathways of potential interests by performing gene expression profiling of tumor tissues before and after exposure to celecoxib.
OUTLINE: This is an open-label, nonrandomized, uncontrolled study.
Patients undergo panendoscopy and tumor biopsy on day 0. Patients receive oral celecoxib twice daily beginning on day 1 and continuing for at least 14 days\*. Patients then undergo definitive surgery.
NOTE: \*Treatment continues until the day before surgery.
Tumor, blood, and urine samples are collected at baseline and periodically during study. Tumor quantification by perfusion CT scan is performed at baseline and after treatment with celecoxib. Biological markers are detected by immunohistochemistry and enzyme immunoassay. Blood vascular density, apoptosis, proliferation, and endothelial cell:tumor ratio are measured by indirect hemagglutination. Gene expression is measured by microarray analysis.
After surgery, patients are followed at 4 weeks and then periodically thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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celecoxib
microarray analysis
protein expression analysis
immunoenzyme technique
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
conventional surgery
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
Principal Investigators
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Francois Luthi, MD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Vaudois
Locations
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Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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Other Identifiers
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CHUV-CEPO-161-05
Identifier Type: -
Identifier Source: secondary_id
EU-20627
Identifier Type: -
Identifier Source: secondary_id
CDR0000490047
Identifier Type: -
Identifier Source: org_study_id