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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Lausanne、スイス、CH-1011
- Centre Hospitalier Universitaire Vaudois
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- マスキング：なし（オープンラベル）
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
|---|
|
Molecular markers of angiogenesis in tumor tissues (PGE2, VEGF, MMP-9, sFlt-1, ERK phosphorylation, PKB phosphorylation, and ErbB2 levels)
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二次結果の測定
結果測定 |
|---|
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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
|
協力者と研究者
捜査官
- スタディチェア：Francois Luthi, MD、Centre Hospitalier Universitaire Vaudois
研究記録日
主要日程の研究
研究開始
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000490047
- CHUV-CEPO-161-05
- EU-20627
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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