NCT00152828已完成1 期
A Phase I/II Trial of the Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy
研究概览
简要总结
This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix cancer. In addition, we aim to determine the effect of celecoxib (Celebrex) on tumour oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis and apoptosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven carcinoma of the cervix, with visible/palpable tumours; FIGO stage T1B-3B, NO/1, MO, to be treated with definitive radiotherapy and chemotherapy
- •ECOG performance status of 0, 1, or 2
- •Adequate hematologic function; Granulocyte count greater than 1.5 x 109/L, Platelet count greater than 100 x 109/L
- •Adequate organ function; Serum creatinine £ 1.25 x ULN, or a calculated creatinine clearance ³ 50 mL/min, Serum bilirubin £ 1.25 x ULN and AST/ALT £ 3xULN
- •No prior treatment for cervix cancer
- •Informed consent
排除标准
- •Use of an NSAID in the 2 weeks prior to study enrollment
- •Patients with an active malignancy at another site
- •Patients with significant cardiac, renal, or pulmonary disease or any other medical conditions that may preclude radical therapy
- •Patients who have significant history of ischaemic heart disease or stroke who would be deemed not suitable for cessation of their daily prophylactic aspirin
- •Patients with history of peptic ulcer disease or previous NSAID related gastrointestinal bleeding
- •Patients with hypersensitivity to NSAIDS or celecoxib, or sulfonamides
- •Patients who unwilling or unable to give informed consent
研究组 & 干预措施
Celecoxib
Experimental
Celecoxib
干预措施: Celecoxib (Drug)
结局指标
主要结局
Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy
时间窗: 1 year
次要结局
- Objective changes in tumour oxygenation and IFP(1 year)
- Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)(1 year)
研究者
研究点 (1)
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