Spots Global Cancer Trial Database for Cholecalciferol(25-[OH]-Vitamin D) in Treating Patients With Colorectal Cancer

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Trial Identification

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

Official Title: 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

Study ID: NCT01403103

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

cholecalciferol

biopsy

protein expression analysis

enzyme-linked immunosorbent assay

laboratory biomarker analysis

reverse transcriptase-polymerase chain reaction

Study Description

Brief 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.