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

23. december 2010 opdateret af: Centre Hospitalier Universitaire Vaudois

Evaluation of the Effect of Celecoxib on Angiogenesis Markers in Patients With Operable Head and Neck Squamous Cell Carcinoma

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.

Studieoversigt

Status

Ukendt

Betingelser

Hoved- og halskræft

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 2
Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Schweiz
- - Lausanne, Schweiz, CH-1011
    - Centre Hospitalier Universitaire Vaudois

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire Vaudois

Efterforskere

Studiestol: Francois Luthi, MD, Centre Hospitalier Universitaire Vaudois

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2006

Datoer for studieregistrering

Først indsendt

26. juli 2006

Først indsendt, der opfyldte QC-kriterier