NCT00066716已完成2 期
A Phase II Study Of Preoperative Celecoxib/Paclitaxel/Carboplatin For Squamous Cell And Adenocarcinoma Of The Esophagus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Pathological response rate at time of surgical resection
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Celecoxib may also stop the growth of tumor cells by stopping blood flow to the tumor and/or may block the enzymes necessary for their growth. Combining celecoxib with paclitaxel and carboplatin before surgery may shrink the tumor so that it can be removed during surgery. Giving celecoxib alone after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving celecoxib together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for esophageal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the rate of complete pathological response and/or minimal residual microscopic disease in patients with squamous cell or adenocarcinoma of the esophagus treated with preoperative celecoxib, paclitaxel, and carboplatin.
Secondary
- Determine the clinical response rate of patients treated with this regimen.
- Determine the chemotherapy-related toxicity of this regimen in these patients.
- Determine the time to progression, disease-free survival, and overall survival of patients treated with this regimen.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed esophageal cancer of 1 of the following cellular types:
- •Squamous cell
- •Adenocarcinoma
- •Potentially resectable disease
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •No bleeding disorder
- •Bilirubin normal
- •AST and ALT less than 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No significant history of unstable cardiovascular disease
- •No inadequately controlled hypertension
- •No angina
- •No myocardial infarction within the past 6 months
- •No ventricular cardiac arrhythmias requiring medication
- •No congestive heart failure that would preclude study therapy
- •Pulmonary function acceptable for surgery
- •No interstitial pneumonia
- •No interstitial fibrosis
- •Gastrointestinal
- •No history of peptic ulcer disease
- •No irritable bowel syndrome
- •No inflammatory bowel disease
- •No chronic diarrhea
- •No bowel obstruction within the past 5 years
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
- •No hypersensitivity to paclitaxel or carboplatin
- •No other serious underlying medical condition that would preclude study therapy
- •No significant psychiatric illness that would preclude study compliance
- •No uncontrolled diabetes mellitus
- •No uncontrolled infection
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- 另有 14 项未显示
排除标准
- 未提供
结局指标
主要结局
Pathological response rate at time of surgical resection
时间窗: At completion of pathology report.
次要结局
- Clinical response rate(At the time of tumor assessment obtained prior to definitive surgery approximately 1-2 weeks prior to surgical resection.)
- Disease-free survival(From start of treatment to time of recurrent disease measured postoperatively every 6 months for 18 months.)
- Overall survival(18 months after surgery)
- Toxicities and safety(30 days after completion of study treatment.)
研究者
研究点 (1)
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