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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014