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Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Vitamin D level

Outcome 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.

Outcome Time Frame:

w/i 6 weeks of beginning vitamin D

Safety Issue:

No

Principal Investigator

Kathleen Wesa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

09-143

NCT ID:

NCT01074216

Start Date:

February 2010

Completion Date:

February 2013

Related Keywords:

  • Colorectal Cancer
  • Vitamin D
  • Vitamin D3
  • colon cancer
  • rectum cancer
  • Cholecalciferol
  • 09-143
  • Colorectal Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memoral Sloan Kettering Cancer Center@Phelps Memorial HospitalSleepy Hollow, New York  
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York