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

NCT00357617 | Unknown Phase 1

• 3 other identifiers: CDR0000490047CHUV-CEPO-161-05EU-20627
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Molecular markers of angiogenesis in tumor tissues (PGE2, VEGF, MMP-9, sFlt-1, ERK phosphorylation, PKB phosphorylation, and ErbB2 levels)

Secondary Outcomes (5)

• Molecular markers in plasma (VEGF, MMP-9, and sFlt1)

• Molecular marker in urine (PGE2)

• Apoptosis/proliferation in tumor cells and endothelial cells

• 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)

• Tumor perfusion imaging by perfusion CT scan

Interventions

celecoxib DRUG

microarray analysis GENETIC

protein expression analysis GENETIC

immunoenzyme technique OTHER

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

biopsy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Celecoxib; Microarray Analysis; Immunoenzyme Techniques; Immunohistochemistry; Biopsy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Microchip Analytical Procedures; Investigative Techniques; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics

Study Officials

• Francois Luthi, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: June 1, 2006
• Last Updated: December 24, 2010

Record last verified: 2008-01

Locations

CH (1)