Loading clinical trials...

Cholecalciferol(25-[OH]-Vitamin D) in Treating Patients With Colorectal Cancer | Clinical Trials | Clareo Health

WITHDRAWNEARLY_PHASE1

Cholecalciferol(25-[OH]-Vitamin D) in Treating Patients With Colorectal Cancer

Evaluation of the Effect of 25-OH-Vitamin D3 Therapy on 15-Prostaglandin Dehydrogenase Expression in Primary Tumor and Normal Colorectal Mucosa in Patients With Colorectal Cancer

NCT01403103•Case Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This pilot clinical trial studies cholecalciferol in treating patients with colorectal cancer. The use of cholecalciferol may slow disease progression in patients with colorectal cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To compare the expression of 15-hydroxyprostaglandin dehydrogenase (PGDH) messenger ribonucleic acid (mRNA) and protein levels in tumor tissue at baseline and after treatment with 25-hydroxy (OH)-vitamin D3 (cholecalciferol). II. To compare the expression of 15-PGDH mRNA and protein levels in normal colorectal mucosa at baseline and following treatment with 25-OH-vitamin D3. SECONDARY OBJECTIVES: I. To compare the expression of cyclooxygenase (COX)-1 and COX-2 mRNA in tumor tissues at baseline and after treatment with 25-OH-vitamin D3. II. To compare levels of prostaglandin E2 (PGE2) in tumor tissue at baseline and after treatment with 25-OH-vitamin D3. III. To compare the expression of COX-1 and COX-2 mRNA in normal colorectal mucosa at baseline and after treatment with 25-OH-vitamin D3. IV. To compare levels of PGE2 in normal colorectal mucosa at baseline and after treatment with 25-OH-vitamin D3. V. To evaluate the tolerability of a single 100,000 international unit (IU) dose of 25-OH-vitamin D3. OUTLINE: Patients receive cholecalciferol orally (PO) 7 days prior to scheduled surgery or endorectal ultrasound. Patients are only followed through surgery or endorectal ultrasound. In case of a vitamin-D-related toxicity, the patient will be followed for resolution of the toxicity, up to 6 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a suspected diagnosis of adenocarcinoma of the rectum or sigmoid colon (e.g. based on appearance of mass or histology) referred to colorectal surgery who are expected to undergo routine proctosigmoidoscopy or flexible sigmoidoscopy in the surgeon's office as well as resection and/or endorectal ultrasound (EUS) as part of their routine care
•The tumor must be accessible for biopsy and suitable for multiple biopsies
•Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
•Able to understand and willing to sign written informed consent document

Exclusion Criteria

•Prior anti-cancer therapy for this cancer such as chemotherapy, biologic therapy, immune therapy or radiation therapy
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Unable to swallow capsules
•Underlying condition that will interfere with absorption of orally ingested vitamin D, e.g., untreated fat malabsorption
•History of allergic reaction to cholecalciferol or other vitamin D preparations
•Elevated ionized calcium
•Primary hyperparathyroidism
•Renal failure with estimated glomerular filtration rate \< 20 mL/min/1.73m\^2 as calculated using the Modification of Diet in Renal Disease (MDRD) study equation for the isotope dilution mass spectrometry (IDMS) - traceable creatinine methods reported by University Hospital Case Medical Center (UHCMC) laboratory (due to less active formation of 1,25 hydroxyvitamin D due to less hydroxylase)
•Serum 25-OH-vitamin D \> 40 ng/ml

Key Dates

Start Date

April 1, 2012

Primary Completion Date

January 1, 2014

Completion Date

January 1, 2014

Last Updated

January 17, 2014

Conditions

Mucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the RectumSignet Ring Adenocarcinoma of the ColonSignet Ring Adenocarcinoma of the RectumStage I Colon CancerStage I Rectal Cancer

Interventions

cholecalciferol

DIETARY_SUPPLEMENT

biopsy

PROCEDURE

protein expression analysis

GENETIC

enzyme-linked immunosorbent assay

OTHER

laboratory biomarker analysis

OTHER

reverse transcriptase-polymerase chain reaction

GENETIC

CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

NCT02232152

Mucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the Rectum+14 more

View study

TERMINATEDPHASE2

Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

NCT03693846

Mucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the Rectum

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cholecalciferol(25-[OH]-Vitamin D) in Treating Patients With Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

Irinotecan-Eluting Beads in Treating Patients With Refractory Metastatic Colon or Rectal Cancer That Has Spread to the Liver

Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care

Cetuximab and/or Dasatinib in Patients With Colorectal Cancer and Liver Metastases That Can Be Removed by Surgery