- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00357617
Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Studienorte
-
-
-
Lausanne, Schweiz, CH-1011
- Centre Hospitalier Universitaire Vaudois
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
---|
Molecular markers of angiogenesis in tumor tissues (PGE2, VEGF, MMP-9, sFlt-1, ERK phosphorylation, PKB phosphorylation, and ErbB2 levels)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
---|
Molecular markers in plasma (VEGF, MMP-9, and sFlt1)
|
Molecular marker in urine (PGE2)
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Apoptosis/proliferation in tumor cells and endothelial cells
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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
|
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Francois Luthi, MD, Centre Hospitalier Universitaire Vaudois
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Plattenepithelkarzinom im Stadium III der Lippe und Mundhöhle
- Plattenepithelkarzinom im Stadium IV der Lippen und der Mundhöhle
- rezidivierendes Plattenepithelkarzinom der Lippen- und Mundhöhle
- Plattenepithelkarzinom des Oropharynx im Stadium III
- Plattenepithelkarzinom des Oropharynx im Stadium IV
- rezidivierendes Plattenepithelkarzinom des Oropharynx
- Plattenepithelkarzinom im Stadium III des Hypopharynx
- Plattenepithelkarzinom des Hypopharynx im Stadium IV
- rezidivierendes Plattenepithelkarzinom des Hypopharynx
- Plattenepithelkarzinom des Kehlkopfes im Stadium III
- Plattenepithelkarzinom des Kehlkopfes im Stadium IV
- rezidivierendes Plattenepithelkarzinom des Kehlkopfes
- Plattenepithelkarzinom im Stadium I der Lippen- und Mundhöhle
- Plattenepithelkarzinom der Lippe und Mundhöhle im Stadium II
- Plattenepithelkarzinom des Hypopharynx im Stadium I
- Plattenepithelkarzinom des Kehlkopfes im Stadium I
- Plattenepithelkarzinom im Stadium I des Oropharynx
- Stadium II Plattenepithelkarzinom des Hypopharynx
- Plattenepithelkarzinom des Kehlkopfes im Stadium II
- Plattenepithelkarzinom im Stadium II des Oropharynx
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Neubildungen nach Standort
- Kopf-Hals-Neubildungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Antirheumatika
- Cyclooxygenase-Inhibitoren
- Cyclooxygenase-2-Inhibitoren
- Celecoxib
Andere Studien-ID-Nummern
- CDR0000490047
- CHUV-CEPO-161-05
- EU-20627
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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