Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00357617
First received: July 26, 2006
Last updated: December 23, 2010
Last verified: January 2008
  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
Genetic: microarray analysis
Genetic: protein expression analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 1
Phase 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Study Chair: Francois Luthi, MD Centre Hospitalier Universitaire Vaudois
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00357617     History of Changes
Other Study ID Numbers: CDR0000490047, CHUV-CEPO-161-05, EU-20627
Study First Received: July 26, 2006
Last Updated: December 23, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014