Status:
TERMINATED
Cholecalciferol and Calcium Carbonate in Treating Patients With Colon Cancer That Has Been Removed by Surgery
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
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 tr...
Detailed Description
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 pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00470353
Start Date
September 1 2006
End Date
September 1 2009
Last Update
August 4 2023
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001