Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib (UAB 0040)

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Pharmacia
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00582660
First received: December 20, 2007
Last updated: September 28, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to assess how effective celecoxib is in limiting production of a hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression of an existing cancer. To answer this question, some subjects are given the new investigational drug, and other subjects a placebo. A placebo is a capsule that contains inactive ingredients. Only by comparing the response of two subject groups, one receiving placebo (inactive), and one receiving celecoxib (active), will we be able to know whether or not celecoxib actually works. The outcome we are assessing is the hormone activity before and after celecoxib is given.


Condition Intervention Phase
Colorectal Adenoma
Colorectal Carcinoma
Drug: Celecoxib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Phase IIB Evaluation of Cyclooxygenase-2 Activity in Surgically Resected Primary Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Enrollment: 41
Study Start Date: December 2001
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
7 day preoperative course of Celecoxib for Colon Cancer that is surgically resectable
Drug: Celecoxib
Celebrex/Celecoxib 400mg PO twice a day for 7 days prior to surgery.
Placebo Comparator: 2
Placebo in a one to one randomization prior to surgery
Drug: Placebo
Placebo/Placebo tablet twice a day for 7 days prior to surgery

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Colon mass

Exclusion Criteria:

  • Allergic to aspirin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582660

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
Pharmacia
Investigators
Principal Investigator: Martin J Heslin, M.D. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Martin Heslin, M.D./Associate Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582660     History of Changes
Other Study ID Numbers: F001228004, NQ8-00-02-008
Study First Received: December 20, 2007
Last Updated: September 28, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenoma
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014