NCT00043043已完成2 期
Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia: Cross-Sectional Prevelance And Modulation By Celecoxib
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Celecoxib may be effective in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.
详细描述
OBJECTIVES:
Primary
- Compare the effects of celecoxib vs placebo on the number of rectal aberrant crypt foci in patients with premalignant rectal polyps or prior sporadic colorectal neoplasia.
Secondary
- Compare the effects of these drugs on proliferation index, apoptotic index, and gene expression patterns in ascending and descending colon tissue from these patients before and after treatment.
- Assess gene expression patterns in normal mucosa from the ascending vs descending colon in patients referred for screening, surveillance, or diagnostic colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
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:
- •Age 18 to 49 with one of the following colorectal abnormalities:
- •At least one adenoma that is at least 1 cm
- •At least 3 adenomas of any size with at least 5 rectal aberrant crypt foci (ACFs)
- •Age 50 and over with one of the following colorectal abnormalities:
- •At least one adenoma that is at least 5 mm and at least 5 rectal ACFs
- •History of polyps (at least 1 adenoma) within the past 5 years
- •No history of germline cancer syndrome
- •No stage III or IV colorectal cancer (Dukes' C or D) diagnosed within the past 6 months
- •No current colorectal cancer
- •No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- •PATIENT CHARACTERISTICS:
- •See Disease Characteristics
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin greater than 11.5 g/dL
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 125,000/mm^3
- •No significant bleeding disorder
- •AST and ALT no greater than 1.5 times upper limit of normal (ULN)
- •Bilirubin no greater than 1.5 times ULN
- •Alkaline phosphatase no greater than 1.5 times ULN
- •No chronic or acute hepatic disorder
- •Creatinine no greater than 1.5 times ULN
- •No chronic or acute renal disorder
- •Cardiovascular
- •No uncontrolled hypertension
- •No unstable angina
- •No congestive heart failure
- •No asthma
- •No severe chronic obstructive pulmonary disease
- •Gastrointestinal
- •No active gastrointestinal ulcers
- •No history of peptic ulcer disease
- •No prior hypersensitivity reaction to NSAIDs, aspirin, or sulfa drugs
- •No medical contraindication to NSAID use
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile female patients must use effective contraception
- •No known allergic reaction to indigo carmine
- •No other clinically significant medical condition or abnormal laboratory value that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- 另有 12 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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