A Phase III Study of Vitamin D3 Supplementation in Addition to the Standard Medical Treatment in Patients with Previously Untreated Metastatic Colorectal Cancer

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Full Title

Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (A021703) (CIRB)

Purpose

A usual treatment for metastatic colorectal cancer is chemotherapy plus bevacizumab, a drug which inhibits the growth of blood vessels that tumors need to grow and spread. Adding high-dose vitamin D3 to the usual treatment could help shrink the cancer or prevent it from returning.

In this study, researchers want to compare the usual treatment plus high-dose vitamin D3 (4000 IU/day) with the usual treatment plus regular-dose vitamin D3 (400 IU/day). Patients will be randomly assigned to receive one treatment regimen or the other. Chemotherapy and bevacizumab are given intravenously (by vein) and vitamin D3 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic colorectal cancer.
  • If patients received prior treatment for nonmetastatic cancer, it must have been completed at least a year before entering the study. Prior radiation therapy for rectal cancer must have been completed at least 4 weeks before entering the study.
  • Patients may not have taken daily vitamin D supplements of 2000 IU or more per day during the year before the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andrea Cercek at 646-888-4189.

Protocol

21-068

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators