Study of Vitamin D in Untreated Metastatic Colorectal Cancer

Description

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.

Study Start Date

March 2012

Estimated Completion Date

July 2016

Interventions

  • Dietary Supplement: Vitamin D
  • Drug: FOLFOX + bevacizumab

Specialties

  • Internal Medicine: Hematology/Oncology,Preventive Medicine
  • Gastroenterology: Colorectal Cancer/Polyps,Parenteral/Ent Nutrition,Pharmacology/kinetics
  • Oncology: Colorectal Cancer/Polyps
  • Nurse Practitioner: Nutrition,Preventive Medicine

MeSH Terms

  • Bevacizumab
  • Colorectal Neoplasms
  • FOLFOX
  • Metastatic Colorectal Cancer
  • Vitamin D

Study ID

Dana-Farber Cancer Institute -- 11-436

Status

Unknown

Trial ID

NCT01516216

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

120

Sponsor

Dana-Farber Cancer Institute

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (12)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.6 miles None None None
VanderbiltIngram Cancer Center - Nashville, Tennessee 944.2 miles None None None
Mountain States Tumor Institute Twin Falls - Twin Falls, Idaho 2,196.8 miles Dan S Zuckerman MD 208-381-2711 None
Mountain States Tumor Institute Twin Falls - Twin Falls, Idaho 2,196.8 miles None None None
Mountain States Tumor Institute at St Lukes Regional Medical Center - Boise, Idaho 2,256.8 miles Dan S Zuckerman MD 208-381-2711 None
Mountain States Tumor Institute at St Lukes Regional Medical Center - Boise, Idaho 2,256.8 miles None None None
Mountain States Tumor Institute Meridian - Meridian, Idaho 2,268.1 miles Dan S Zuckerman MD 208-381-2711 None
Mountain States Tumor Institute Meridian - Meridian, Idaho 2,268.1 miles None None None
Mountain States Tumor Institute Nampa - Nampa, Idaho 2,277.9 miles None None None
Mountain States Tumor Institute Fruitland - Fruitland, Idaho 2,286.7 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.