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Study of Vitamin D in Untreated Metastatic Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kimmie Ng, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01516216
First received: January 13, 2012
Last updated: February 7, 2017
Last verified: February 2017
  Purpose

The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cell death. Vitamin D has been used in other research studies and information from those other research studies suggests that Vitamin D may help in the treatment of colorectal cancer.

In this research study, the investigators are comparing standard and higher dose Vitamin D treatment when given in combination with standard treatment for metastatic colorectal cancer. Standard treatment includes the chemotherapy combination of 5-FU, Leucovorin and Oxaliplatin (FOLFOX) with bevacizumab.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: FOLFOX + bevacizumab
Dietary Supplement: Vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Phase II Trial of Vitamin D Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2 years ]
    To compare the progression-free survival (PFS) of participants with previously untreated metastatic colorectal cancer randomized to FOLFOX-bevacizumab plus higher-dose vitamin D versus FOLFOX-bevacizumab plus standard-dose vitamin D


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ]
    To compare the overall survival (OS) of participants with previously untreated metastatic colorectal cancer randomized to FOLFOX-bevacizumab plus higher-dose vitamin D versus FOLFOX-bevacizumab plus standard-dose vitamin D

  • Objective tumor response rate [ Time Frame: 2 years ]
    To compare the objective tumor response rate (RR) of participants with previously untreated metastatic colorectal cnacer randomized to FOLFOX-bevacizumab plus higher-dose vitamin D versus FOLFOX-bevacizumab plus standard-dose vitamin D

  • Safety [ Time Frame: 2 years ]
    To evaluate and compare the toxicity of adding higher-dose vitamin D versus standard-dose vitamin D to FOLFOX-bevacizumab

  • Incidence of vitamin D deficiency [ Time Frame: 2 years ]
    To evaluate the incidence of vitamin D deficiency in participants with previously untreated metastatic colorectal cancer

  • Proportion of participants able to achieve and maintain vitamin D sufficiency [ Time Frame: 2 years ]
    To compare the proportion of participants who are able to achieve and maintain vitamin D sufficiency with higher-dose vitamin D versus standard-dose vitamin D

  • Time course of change in plasma 25-hydroxyvitamin D3 levels [ Time Frame: 2 years ]
    To compare the time course of change in plasma 25-hydroxyvitamin D3 [25(OH)D] levles in participants randomized to higher-dose vitamin D versus standard-dose vitamin D

  • Association between plasma 25(OH)D levels and PFS and OS [ Time Frame: 2 years ]
    To evaluate the association between plasma 25(OH)D levels and PFS and overall survival


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Dose Vitamin D
Standard Dose Vitamin D with Bevacizumab and FOLFOX. FOLFOX contains: 5-FU (5-fluorouracil), Leucovorin and Oxaliplatin (Eloxatin).
Drug: FOLFOX + bevacizumab
Given intravenously on Day 1 of every cycle
Other Names:
  • 5-FU (5-fluorouracil)
  • Leucovorin
  • Oxaliplatin (Eloxatin)
  • Bevacizumab (Avastin)
Dietary Supplement: Vitamin D
Standard Dose (400 IU once daily)
Active Comparator: Higher Dose Vitamin D
Higher Dose Vitamin D with Bevacizumab and FOLFOX. FOLFOX contains: 5-FU (5-fluorouracil), Leucovorin and Oxaliplatin (Eloxatin).
Drug: FOLFOX + bevacizumab
Given intravenously on Day 1 of every cycle
Other Names:
  • 5-FU (5-fluorouracil)
  • Leucovorin
  • Oxaliplatin (Eloxatin)
  • Bevacizumab (Avastin)
Dietary Supplement: Vitamin D
Higher Dose (8000 IU once daily for 2 weeks, followed by 4000 IU once daily)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic or locally advanced (unresectable)
  • Measurable disease
  • KRAS wild-type and KRAS mutant patients are eligible
  • No prior systemic treatment for advanced or metastatic colorectal cancer is allowed
  • No prior radiotherapy to more than 25% of bone marrow
  • No surgery or major biopsy within 4 weeks of randomization
  • Paraffin-embedded and/or snap-frozen tumor tissue samples must be available

Exclusion Criteria:

  • Not pregnant or breastfeeding
  • No prior chemotherapy, systemic therapy or investigational agent
  • No concurrent use of other anti-cancer therapy
  • No known brain metastases
  • No history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, curatively treated lobular or ductal carcinoma in situ of the breast or other cancer curatively treated with no evidence of disease for more than 3 years prior to randomization
  • No regular use of vitamin D supplements greater than 2000 IU per day in the past year
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-FU, capecitabine, oxaliplatin, leucovorin, bevacizumab and/or vitamin D3
  • No significant history of bleeding events, pre-existing bleeding diathesis, coagulopathy or gastrointestinal perforation
  • No arterial thrombotic events within 6 months of randomization
  • No serious non-healing wound, ulcer or bone fracture
  • No history of uncontrolled hypertension
  • No clinically significant peripheral neuropathy
  • No predisposing colonic or small bowel disorders in which the symptoms are uncontrolled
  • No uncontrolled seizure disorder or active neurological disease
  • No pre-existing hypercalcemia
  • No known active hyperparathyroid disease
  • No regular use of thiazide diuretics
  • No malabsorption, uncontrolled vomiting or diarrhea
  • No known co-morbid disease that would increase the risk of toxicity
  • No use of chronic oral corticosteroid therapy or any other therapy that can cause vitamin D depletion
  • No clinically significant cardiovascular disease
  • No uncontrolled intercurrent illness
  • No history of any medical or psychiatric condition or addictive disorder or laboratory abnormality that may increase the risks associated with study participation
  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: NCT01516216

Locations
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
Mountain States Tumor Institute- Fruitland
Fruitland, Idaho, United States, 83619
Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Mountain States Tumor Institute- Nampa
Nampa, Idaho, United States, 83686
Mountain States Tumor Institute- Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
The Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Lowell General Hospital
Lowell, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
South Weymouth, Massachusetts, United States
United States, New Hampshire
New Hampshire Oncology Hematology-P.A.
Concord, New Hampshire, United States
New Hampshire Oncology Hematology-P.A.
Hooksett, New Hampshire, United States
New Hampshire Oncology Hematology-P.A.
Laconia, New Hampshire, United States
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire, United States
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Kimmie Ng, MD, MPH Dana-Farber Cancer Institute
  More Information

Responsible Party: Kimmie Ng, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01516216     History of Changes
Other Study ID Numbers: 11-436 
Study First Received: January 13, 2012
Last Updated: February 7, 2017

Keywords provided by Dana-Farber Cancer Institute:
previously untreated

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
Bevacizumab
Oxaliplatin
Fluorouracil
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 17, 2017