NCT01403103

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucinous Adenocarcinoma of the Colon
• Mucinous Adenocarcinoma of the Rectum
• Signet Ring Adenocarcinoma of the Colon
• Signet Ring Adenocarcinoma of the Rectum
• Stage I Colon Cancer
• Stage I Rectal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol	Given PO
PROCEDURE	biopsy	Correlative studies
GENETIC	protein expression analysis	Correlative studies
OTHER	enzyme-linked immunosorbent assay	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
GENETIC	reverse transcriptase-polymerase chain reaction	Correlative studies

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-07-27
• Last updated: 2014-01-17