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Cholecalciferol and Calcium Carbonate in Treating Patients With Colon Cancer That Has Been Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00470353
Recruitment Status : Terminated (Withdrawn due to poor accrual/lack of funding)
First Posted : May 7, 2007
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):

Study Description
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 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.

Condition or disease Intervention/treatment
Colorectal Cancer Dietary Supplement: calcium carbonate Dietary Supplement: cholecalciferol Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: biopsy

Detailed Description:



  • 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.


  • 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.

OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral low-dose cholecalciferol once daily and oral calcium carbonate twice daily.
  • Arm II: Patients receive oral high-dose cholecalciferol once daily and calcium carbonate as in arm I.

Treatment in both arms continues for up to 2 years in the absence of disease progression or unacceptable toxicity. All patients undergo sigmoidoscopy or colonoscopy with 4 quadrant mucosal biopsies at baseline and after 6 months of study treatment. After their 6-month mucosal biopsy, patients in arm I switch to high-dose cholecalciferol as in arm II.

Patients undergo blood, urine, and tissue collection periodically during study for pharmacokinetic, pharmacodynamic, and/or histopathological analysis. Serum is collected monthly for 3 months and then once every 3 months to assess changes in serum levels of vitamin D and vitamin D metabolites (i.e., 1,25-OH-D3; 25-OH-D3; 24,25-OH-D3), as well as changes in calcium and parathyroid hormone, BUN, creatinine, electrolytes, and phosphorus levels. Urine is collected once every 3 months to assess changes in urine calcium and creatinine levels for hypercalciuria. Tissue biopsies of normal endorectal mucosa collected at baseline and after 6 months of study treatment are evaluated by IHC for proliferative index, vitamin D receptor staining, p21, p27, cyclin D1, and protein kinase C.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Pilot Study of Low and High Dose Vitamin Cholecalciferol (D3) With Pharmacokinetic and Pharmacodynamic Correlates in Patients With Resected Colon Cancer
Study Start Date : September 2006
Primary Completion Date : July 2008
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Change in proliferative labeling index of normal rectal mucosa as measured by Ki67 IHC staining

Secondary Outcome Measures :
  1. Changes in serum levels of 25-OH-D3, 1,25-OH-D3, 24,25-OH-D3, calcium, and parathyroid hormone
  2. Safety of high-dose cholecalciferol supplementation as measured over 2 years [ Time Frame: over 2 years ]
  3. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • History of colon cancer

    • Underwent resection and has been in clinical remission for ≥ 1 year
  • No inflammatory bowel disease
  • No familial adenomatous polyposis


  • 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


  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470353

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Marwan Fakih, MD Roswell Park Cancer Institute
More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00470353     History of Changes
Other Study ID Numbers: I 78706
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by Roswell Park Cancer Institute:
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Growth Substances
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents