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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT00470353 |
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Date of registration:
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03/05/2007 |
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Primary sponsor: |
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Public title:
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Cholecalciferol and Calcium Carbonate in Treating Patients With Colon Cancer That Has Been Removed by Surgery
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Scientific title:
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A Pilot Study of Low and High Dose Vitamin Cholecalciferol (D3) With Pharmacokinetic and Pharmacodynamic Correlates in Patients With Resected Colon Cancer |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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8 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00470353 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Marwan Fakih, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Roswell Park Cancer Institute |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Dietary Supplement: calcium carbonate
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Dietary Supplement: cholecalciferol
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Other: immunohistochemistry staining method
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Other: laboratory biomarker analysis
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Other: pharmacological study
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Procedure: biopsy
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Primary Outcome(s)
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Change in proliferative labeling index of normal rectal mucosa as measured by Ki67 IHC staining
[Time Frame: No]
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Secondary Outcome(s)
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Changes in serum levels of 25-OH-D3, 1,25-OH-D3, 24,25-OH-D3, calcium, and parathyroid hormone
[Time Frame: No]
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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
[Time Frame: No]
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Safety of high-dose cholecalciferol supplementation as measured over 2 years
[Time Frame: over 2 years]
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Secondary ID(s)
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I 78706
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RPCI-I-78706
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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