Vitamin D Levels in Stage IV Colorectal Cancer Patients

Overview

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.

Full Title of Study: “Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • To Achieve Target Vitamin D Level
    • Time Frame: Within 6 weeks of beginning vitamin D
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kathleen Wesa, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

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