Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis (PreDuoFAP)

This study has been completed.
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00808743
First received: December 15, 2008
Last updated: May 15, 2013
Last verified: August 2010
  Purpose

Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.


Condition Intervention Phase
Familial Adenomatous Polyposis
Duodenal Neoplasms
Duodenal Polyps
Drug: Celecoxib
Drug: Ursodeoxycholic acid
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cell proliferation, in normal mucosa and adenomas (if present) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Biliary acid profile (if present) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: May 2009
Study Completion Date: January 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Patients receive oral celecoxib twice daily and oral placebo twice daily
Drug: Celecoxib
Celecoxib: 400mg twice daily, orally, 6 months
Drug: Placebo

Placebo: orally, 6 months, dosage based on body weight:

below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses

Experimental: Group 2
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
Drug: Celecoxib
Celecoxib: 400mg twice daily, orally, 6 months
Drug: Ursodeoxycholic acid

Ursodeoxycholic acid: orally, 6 months, dosage based on body weight:

below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
  • Spigelman score of duodenal adenoma equal to II or III

Exclusion Criteria:

  • Incapability of signing informed consent
  • Active gastric or duodenal ulcer, gastrointestinal bleeding
  • Cardiovascular disease or risk:

    • Congestive cardiac failure: NYHA class II to IV
    • Proven ischemic heart disease and/or cerebrovascular disease
    • Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members <55 years)
  • Renal dysfunction: creatinine clearance below 50mL/min
  • Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
  • Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid
  • Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study
  • Use of lithium
  • Symptomatic gallstones
  • Inflammatory bowel disease
  • (Possible) pregnancy or breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808743

Locations
Netherlands
Academic Medical Center
Amsterdam, Netherlands
University Medical Center
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
University Medical Center St. Radboud
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Radboud University
Dutch Cancer Society
Investigators
Principal Investigator: Fokko M Nagengast, MD, Ph D University Medical Center St. Radboud Nijmegen, The Netherlands
Principal Investigator: Bjorn WH van Heumen, MD University Medical Center St. Radboud Nijmegen, The Netherlands
Principal Investigator: Wilbert HM Peters, Ph D University Medical Center St Radboud Nijmegen, The Netherlands
Principal Investigator: Ellen Kampman, Ph D University Medical Center St Radboud Nijmegen, The Netherlands
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00808743     History of Changes
Other Study ID Numbers: RUN 2008-4198, ABR nr.: NL23569.091.08, CMO: 2008/148, EudraCT: 2008-003696-43
Study First Received: December 15, 2008
Last Updated: May 15, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Familial adenomatous polyposis
Adenomatous Polyposis Coli
Digestive System Neoplasms
Gastrointestinal Disease
Intestinal disease
Intestinal neoplasms
Gastrointestinal neoplasms
Polyps
Adenoma
Adenomatous Polyps
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Genetic Diseases, Inborn
Chemoprevention
Celecoxib
Ursodeoxycholic acid
Anti-Inflammatory agents, Non-Steroidal
Cyclooxygenase Inhibitors

Additional relevant MeSH terms:
Adenoma
Neoplasms
Duodenal Neoplasms
Adenomatous Polyposis Coli
Polyps
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Adenomatous Polyps
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Colonic Diseases
Intestinal Polyposis
Genetic Diseases, Inborn
Pathological Conditions, Anatomical
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on July 29, 2014