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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Withdrawn; Early Phase 1

Conditions: Signet Ring Adenocarcinoma of the Colon; Mucinous Adenocarcinoma of the Rectum; Signet Ring Adenocarcinoma of the Rectum; Mucinous Adenocarcinoma of the Colon; Stage I Colon Cancer; Stage I Rectal Cancer

Treatments: Genetic: protein expression analysis; Dietary Supplement: cholecalciferol; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis; Procedure: biopsy; Other: enzyme-linked immunosorbent assay

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01403103

NCI-2011-01280 (Registry Identifier)

CASE2210

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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
• EXCLUSION CRITERIA FOR DOSING VITAMIN D:
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment (chemoprevention)

Experimental group

Description:

Patients receive cholecalciferol orally (PO) 7 days prior to scheduled surgery or endorectal ultrasound. Patients with sigmoid colon cancer or clinical stage I rectal cancer would proceed with surgical resection without preceding chemoradiation and will have a portion of normal colorectal mucosa and tumor tissue obtained for research purposes.

Treatment:

Other: enzyme-linked immunosorbent assay

Procedure: biopsy

Other: laboratory biomarker analysis

Genetic: protein expression analysis

Genetic: reverse transcriptase-polymerase chain reaction

Dietary Supplement: cholecalciferol