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

NCT00470353 | Terminated

• 2 other identifiers: I 78706RPCI-I-78706
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage I colon cancer; stage II colon cancer; stage III colon cancer

Outcome Measures

Primary Outcomes (1)

• Change in proliferative labeling index of normal rectal mucosa as measured by Ki67 IHC staining

Secondary Outcomes (3)

• 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

• 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

Interventions

calcium carbonate DIETARY_SUPPLEMENT

cholecalciferol DIETARY_SUPPLEMENT

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Calcium Carbonate; Cholecalciferol; Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Marwan Fakih, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: September 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2009
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

US (1)