NCT00470353终止不适用
A Pilot Study of Low and High Dose Vitamin Cholecalciferol (D3) With Pharmacokinetic and Pharmacodynamic Correlates in Patients With Resected Colon Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in proliferative labeling index of normal rectal mucosa as measured by Ki67 IHC staining
研究概览
简要总结
RATIONALE: The use of cholecalciferol and calcium carbonate may keep colon cancer from coming back in patients with colon cancer that has been removed by surgery.
PURPOSE: This randomized clinical trial is studying two different doses of cholecalciferol to compare how well they work when given together with calcium carbonate in treating patients with colon cancer that has been removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the antiproliferative effects of 2 different doses of cholecalciferol (i.e., vitamin D3) in combination with calcium carbonate on the proliferative labeling index in patients with resected colon cancer.
Secondary
- Compare the effects of these doses on serum levels of 25-OH-D3, 1,25-OH-D3, 24,25-OH-D3, calcium, and parathyroid hormone in these patients.
- Determine the safety of high-dose cholecalciferol in these patients over 2 years.
- Compare the effects of these doses on several biological markers (i.e., cyclin D1, protein kinase C, vitamin D receptor, p21, and p27) in the rectal mucosa of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •History of colon cancer
- •Underwent resection and has been in clinical remission for ≥ 1 year
- •No inflammatory bowel disease
- •No familial adenomatous polyposis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 1 year
- •No genitourinary stones within the past 5 years
- •No severe comorbid conditions, such as uncompensated heart failure or active uncontrolled infection
- •No history of hypercalcemia
- •No active colostomy
- •No contraindications to sigmoidoscopy or mucosal biopsies
- •PRIOR CONCURRENT THERAPY:
- •No prior rectal surgery or abdominoperineal resection
- •At least 1 month since prior vitamin D or calcium supplementation
- •Prior vitamin D supplemental intake ≤ 800 IU per day
- •At least 1 year since prior chemotherapy
- •No prior radiotherapy to the pelvis
- •No concurrent active anticoagulation
- •Patients who stop anticoagulation therapy at the time of mucosal biopsy are eligible
- •No other concurrent supplemental calcium or vitamin D
排除标准
- 未提供
结局指标
主要结局
Change in proliferative labeling index of normal rectal mucosa as measured by Ki67 IHC staining
次要结局
- Effects of cholecalciferol on biological markers of proliferation (i.e., cyclin D1, protein kinase C, vitamin D receptor, p21, and p27) as measured by IHC at baseline and after 6 months of study treatment
- Changes in serum levels of 25-OH-D3, 1,25-OH-D3, 24,25-OH-D3, calcium, and parathyroid hormone
- Safety of high-dose cholecalciferol supplementation as measured over 2 years(over 2 years)
研究者
研究点 (1)
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