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Vitamin D Levels in Stage IV Colorectal Cancer Patients

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Vitamin D, Vitamin D3, colon cancer, rectum cancer, Cholecalciferol, 09-143

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with Stage IV (metastatic) colorectal cancer
  • Baseline 25-hydroxy vitamin D level < 30 ng/ml
  • Age ≥18 years of age

Exclusion Criteria:

  • Current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years
  • Albumin < 3.2
  • Patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids
  • Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine
  • Hypercalcemia (Calcium >10.5 mg/dl)
  • Calcium x Phosphorus > 70 mg2/dL2

Sites / Locations

  • Memoral Sloan Kettering Cancer Center
  • Memorial Sloan-Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan-Kettering at Mercy Medical Center
  • Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vitamin D, vitamin D3

Arm Description

This is a Phase II study involving Stage IV colorectal cancer patients with serum vitamin D deficiency, to determine the ability to correct vitamin D deficiency and to maintain serum vitamin D levels (25-hydroxy vitamin D) once achieved.

Outcomes

Primary Outcome Measures

To Achieve Target Vitamin D Level
To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks

Secondary Outcome Measures

Full Information

First Posted
February 22, 2010
Last Updated
January 4, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01074216
Brief Title
Vitamin D Levels in Stage IV Colorectal Cancer Patients
Official Title
Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Vitamin D, Vitamin D3, colon cancer, rectum cancer, Cholecalciferol, 09-143

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D, vitamin D3
Arm Type
Experimental
Arm Description
This is a Phase II study involving Stage IV colorectal cancer patients with serum vitamin D deficiency, to determine the ability to correct vitamin D deficiency and to maintain serum vitamin D levels (25-hydroxy vitamin D) once achieved.
Intervention Type
Drug
Intervention Name(s)
vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Intervention Description
Patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
Primary Outcome Measure Information:
Title
To Achieve Target Vitamin D Level
Description
To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks
Time Frame
Within 6 weeks of beginning vitamin D

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Stage IV (metastatic) colorectal cancer Baseline 25-hydroxy vitamin D level < 30 ng/ml Age ≥18 years of age Exclusion Criteria: Current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years Albumin < 3.2 Patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine Hypercalcemia (Calcium >10.5 mg/dl) Calcium x Phosphorus > 70 mg2/dL2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Wesa, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan-Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
City
Sleepy Hollow
State/Province
New York
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center

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Vitamin D Levels in Stage IV Colorectal Cancer Patients

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