Vitamin D Levels in Stage IV Colorectal Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01074216
First received: February 22, 2010
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Vitamin D level [ Time Frame: w/i 6 weeks of beginning vitamin D ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • length of time required to achieve serum vitamin D levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the length of time required to achieve serum vitamin D levels ≥40 ng/ml through vitamin D supplementation in patients with metastatic colon cancer.

  • ability to maintain serum vitamin D levels ≥40 ng/ml [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The ability to maintain serum vitamin D levels ≥40 ng/ml with daily vitamin D maintenance.

  • describe serial PTH levels and explore the correlation between normalization of vitamin D levels and normalization of PTH levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To describe serial PTH levels and explore the correlation between normalization of vitamin D levels and normalization of PTH levels in metastatic colon cancer patients.

  • To explore interactions between other medications and vitamin D repletion. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the safety of vitamin D supplementation. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To estimate overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D, vitamin D3
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.
Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074216

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York, United States
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Kathleen Wesa, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01074216     History of Changes
Other Study ID Numbers: 09-143
Study First Received: February 22, 2010
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Vitamin D
Vitamin D3
colon cancer
rectum cancer
Cholecalciferol
09-143

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 23, 2014