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

This study has been withdrawn prior to enrollment.
(Slow Accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01403103
First received: July 25, 2011
Last updated: January 16, 2014
Last verified: January 2014

July 25, 2011
January 16, 2014
April 2012
January 2014   (final data collection date for primary outcome measure)
  • Comparison of the expression of 15-PGDH mRNA and protein levels in tumor tissue [ Time Frame: 7-14 days after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7-14 days after treatment ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01403103 on ClinicalTrials.gov Archive Site
  • Comparison of the expression of COX-1 and COX-2 mRNA in tumor tissues [ Time Frame: 7-14 days after treatment ] [ Designated as safety issue: No ]
  • Comparison of levels of PGE2 in tumor tissue [ Time Frame: 7-14 days after treatment ] [ Designated as safety issue: No ]
  • Comparison of the expression of COX-1 and COX-2 mRNA in normal colorectal mucosa [ Time Frame: 7-14 days after treatment ] [ Designated as safety issue: No ]
  • Comparison of levels of PGE2 in normal colorectal mucosa [ Time Frame: 7-14 days after treatment ] [ Designated as safety issue: No ]
  • Number of patients with grade 3 related toxicities of a single 100,000 IU dose of 25-OH-vitamin D3 [ Time Frame: 18-25 days after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
  • Dietary Supplement: cholecalciferol
    Given PO
    Other Names:
    • Calciol
    • Vitamin D3
  • Procedure: biopsy
    Correlative studies
    Other Name: biopsies
  • Genetic: protein expression analysis
    Correlative studies
  • Other: enzyme-linked immunosorbent assay
    Correlative studies
    Other Name: ELISA
  • Other: laboratory biomarker analysis
    Correlative studies
  • Genetic: reverse transcriptase-polymerase chain reaction
    Correlative studies
    Other Name: RT-PCR
Experimental: Treatment (chemoprevention)
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.
Interventions:
  • Dietary Supplement: cholecalciferol
  • Procedure: biopsy
  • Genetic: protein expression analysis
  • Other: enzyme-linked immunosorbent assay
  • Other: laboratory biomarker analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01403103
CASE2210, NCI-2011-01280
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: 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
Case Comprehensive Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP