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
Conditions
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.
Interventions
DIETARY_SUPPLEMENTcholecalciferol
Given PO
PROCEDUREbiopsy
Correlative studies
GENETICprotein expression analysis
Correlative studies
OTHERenzyme-linked immunosorbent assay
Correlative studies
OTHERlaboratory biomarker analysis
Correlative studies
GENETICreverse transcriptase-polymerase chain reaction
Correlative studies
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the expression of 15-PGDH mRNA and protein levels in tumor tissue | 7-14 days after treatment | An increase in 15-PGDH expression will be defined as at least a 100% increase in mRNA by real-time reverse transcriptase (RT)-polymerase chain reaction (PCR) compared to baseline. Expression of 15-PGDH protein via ELISA in normal and tumor tissue at baseline and following treatment with vitamin D, as well as the absolute and fold changes will be summarized with descriptive statistics (e.g., mean, median, standard deviation, and interquartile range) and using box plots. In addition, 95% confidence intervals for the mean absolute and fold-changes in 15-PGDH levels will be calculated. |
| Comparison of the expression of 15-PGDH mRNA and protein levels in normal colorectal mucosa | 7-14 days after treatment | An increase in 15-PGDH expression will be defined as at least a 100% increase in mRNA by real-time reverse transcriptase (RT)-polymerase chain reaction (PCR) compared to baseline. Expression of 15-PGDH protein via ELISA in normal and tumor tissue at baseline and following treatment with vitamin D, as well as the absolute and fold changes will be summarized with descriptive statistics (e.g., mean, median, standard deviation, and interquartile range) and using box plots. In addition, 95% confidence intervals for the mean absolute and fold-changes in 15-PGDH levels will be calculated. |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the expression of COX-1 and COX-2 mRNA in normal colorectal mucosa | 7-14 days after treatment |
| Comparison of the expression of COX-1 and COX-2 mRNA in tumor tissues | 7-14 days after treatment |
| Number of patients with grade 3 related toxicities of a single 100,000 IU dose of 25-OH-vitamin D3 | 18-25 days after treatment |
| Comparison of levels of PGE2 in normal colorectal mucosa | 7-14 days after treatment |
| Comparison of levels of PGE2 in tumor tissue | 7-14 days after treatment |
Outcome results
None listed