Vitamin D Levels in Stage IV Colorectal Cancer Patients - Full Text View

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:

MedlinePlus related topics: Cancer Colorectal Cancer Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	February 2013 (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:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

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, 2012
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 June 18, 2013