Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery - Full Text View

Sponsored by:	Centre Hospitalier Universitaire Vaudois
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00357617

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: celecoxib Procedure: biopsy Procedure: conventional surgery Procedure: gene expression profiling Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: protein expression analysis	Phase I Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Urine and Urination

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled
Official Title:	Evaluation of the Effect of Celecoxib on Angiogenesis Markers in Patients With Operable Head and Neck Squamous Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Molecular markers of angiogenesis in tumor tissues (PGE2, VEGF, MMP-9, sFlt-1, ERK phosphorylation, PKB phosphorylation, and ErbB2 levels) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Molecular markers in plasma (VEGF, MMP-9, and sFlt1) [ Designated as safety issue: No ]
Molecular marker in urine (PGE2) [ Designated as safety issue: No ]
Apoptosis/proliferation in tumor cells and endothelial cells [ Designated as safety issue: No ]
Gene expression profiling in fresh tumor tissues (Erb-B2, c-IAP-2, PAI-1, MAPK-4, integrin α V, N-CAM, caspase 6, ErbB2 transducer, angiopoietin like-2, interleukin-8, and MMP13) [ Designated as safety issue: No ]
Tumor perfusion imaging by perfusion CT scan [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2006

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357617

Locations

Switzerland
Centre Hospitalier Universitaire Vaudois	Recruiting
Lausanne, Switzerland, CH-1011
Contact: Francois Luthi, MD 41-213-140-155

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

Study Chair:

Francois Luthi, MD

Centre Hospitalier Universitaire Vaudois

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000490047, CHUV-CEPO-161-05, EU-20627
Study First Received:	July 26, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00357617
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Epidermoid carcinoma
Celecoxib
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma

Hypopharyngeal cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009