NCT00258232已完成2 期
Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 3
- 主要终点
- Response rate by RECIST criteria at every other course
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with capecitabine and irinotecan may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving celecoxib together with capecitabine and irinotecan works in treating patients with recurrent or metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with celecoxib, capecitabine, and irinotecan.
Secondary
- Determine the time to progression in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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 adenocarcinoma of the colon or rectum
- •Locally recurrent or metastatic disease
- •Measurable disease, defined as ≥ 1 measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan
- •Bone metastases, ascites, and pleural effusion are not considered measurable disease
- •Measurable lesions must be located outside a previously irradiated field
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •No Gilbert's disease
- •Creatinine clearance > 50 mL/min
- •Cardiovascular
- •No clinically significant cardiac disease that is not well controlled by medication, including any of the following conditions:
- •Congestive heart failure
- •Symptomatic coronary artery disease
- •Cardiac arrhythmias
- •No myocardial infarction within the past year
- •Gastrointestinal
- •Must have a physically intact upper gastrointestinal tract
- •Able to swallow tablets
- •No history of peptic ulcer disease or gastroesophageal reflux
- •No malabsorption syndrome
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known HIV positivity
- •No asthma, urticaria, or allergic-type reaction after prior treatment with aspirin or other nonsteroidal anti-inflammatory drugs
- •No other malignancy except curatively treated cancer with no evidence of active disease
- •No unresolved bacterial infection requiring antibiotics
- •No other serious infection
- •No known allergy to study drugs or sulfa drugs
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for colorectal cancer
- •Patients relapsing > 6 months after completion of prior adjuvant chemotherapy allowed
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy
- •No concurrent anticancer radiotherapy
- •Recovered from prior surgery
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate by RECIST criteria at every other course
次要结局
- Overall survival
- Time to treatment failure
- Time to progression
- Toxicity
研究者
研究点 (3)
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