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

This study has been terminated.
(Withdrawn due to poor accrual/lack of funding)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00470353
First received: May 3, 2007
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Change in proliferative labeling index of normal rectal mucosa as measured by Ki67 IHC staining [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in serum levels of 25-OH-D3, 1,25-OH-D3, 24,25-OH-D3, calcium, and parathyroid hormone [ Designated as safety issue: No ]
  • Safety of high-dose cholecalciferol supplementation as measured over 2 years [ Time Frame: over 2 years ] [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2006
Study Completion Date: September 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470353

Locations
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)
Investigators
Principal Investigator: Marwan Fakih, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00470353     History of Changes
Other Study ID Numbers: I 78706, RPCI-I-78706
Study First Received: May 3, 2007
Last Updated: January 31, 2013
Health Authority: United States: Federal Government

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:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Calcium Carbonate
Cholecalciferol
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 23, 2013