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

NCT01403103 | Withdrawn Early Phase 1 DMC

• 2 other identifiers: CASE2210NCI-2011-01280
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• Comparison of the expression of 15-PGDH mRNA and protein levels in tumor tissue

  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.

  7-14 days after treatment

• Comparison of the expression of 15-PGDH mRNA and protein levels in normal colorectal mucosa

  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.

  7-14 days after treatment

Secondary Outcomes (5)

• Comparison of the expression of COX-1 and COX-2 mRNA in tumor tissues

  7-14 days after treatment

• Comparison of levels of PGE2 in tumor tissue

  7-14 days after treatment

• Comparison of the expression of COX-1 and COX-2 mRNA in normal colorectal mucosa

  7-14 days after treatment

• Comparison of levels of PGE2 in normal colorectal mucosa

  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

Study Arms (1)

Treatment (chemoprevention)

EXPERIMENTAL

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.

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

Interventions

cholecalciferol DIETARY_SUPPLEMENT

Given PO

Also known as: Calciol, Vitamin D3

Treatment (chemoprevention)

biopsy PROCEDURE

Correlative studies

Also known as: biopsies

Treatment (chemoprevention)

protein expression analysis GENETIC

Correlative studies

Treatment (chemoprevention)

enzyme-linked immunosorbent assay OTHER

Correlative studies

Also known as: ELISA

Treatment (chemoprevention)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemoprevention)

reverse transcriptase-polymerase chain reaction GENETIC

Correlative studies

Also known as: RT-PCR

Treatment (chemoprevention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Cholecalciferol; Biopsy; Enzyme-Linked Immunosorbent Assay; Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques

Study Officials

• Smitha Krishnamurthi, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Matthew Kalady, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: April 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 17, 2014

Record last verified: 2014-01