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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033371 |
Purpose
RATIONALE: The use of celecoxib with or without eflornithine may be an effective way to prevent colorectal cancer in patients who have familial adenomatous polyposis.
PURPOSE: Randomized phase II trial to compare the effectiveness of celecoxib with or without eflornithine in preventing colorectal cancer in patients who have familial adenomatous polyposis.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Precancerous/Nonmalignant Condition |
Drug: celecoxib Drug: eflornithine Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Two Arm Phase II Chemoprevention Trial In Adenomatous Polyposis Coli Patients |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2001 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Active Comparator
Patients receive oral celecoxib twice daily and oral placebo once daily.
|
Drug: celecoxib
Given orally
Other: placebo
Given orally
|
|
Arm II: Experimental
Patients receive celecoxib as in arm I and oral eflornithine once daily.
|
Drug: celecoxib
Given orally
Drug: eflornithine
Given orally
|
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms.
Treatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1-2 months after end of study therapy.
PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study within 13 months.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of familial adenomatous polyposis (FAP) of the colorectum based on 1 of the following criteria:
More than 10 polyps and under age 40 OR more than 25 polyps and over age 40
Must have characteristic family history (autosomal dominant pattern), including 1 of the following:
Colonic and/or rectal segment endoscopy documenting 1 of the following:
5 or more colon polyps each at least 2 mm in diameter, including 1 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Cardiovascular
Endocrine
Hematopoietic:
Hepatic:
Renal:
Other:
No clinically significant hearing loss, defined as:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| United Kingdom, England | |
| St. Mark's Hospital | |
| Harrow, England, United Kingdom, HA1 3UJ | |
| Study Chair: | Patrick M. Lynch, MD, JD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M. D. Anderson Cancer Center at University of Texas ( Patrick M. Lynch ) |
| Study ID Numbers: | CDR0000069278, MDA-ID-00109, NCI-P02-0219 |
| Study First Received: | April 9, 2002 |
| Last Updated: | June 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00033371 History of Changes |
| Health Authority: | United States: Federal Government |
|
colon cancer rectal cancer familial adenomatous polyposis precancerous/nonmalignant condition |
|
Anti-Inflammatory Agents Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Precancerous Conditions Gastrointestinal Diseases Adenomatous Polyposis Coli Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases Rectal Diseases Antiparasitic Agents Neoplasms by Site Sensory System Agents |
Eflornithine Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Adenomatous Polyps Digestive System Neoplasms Neoplasms by Histologic Type Intestinal Polyposis Celecoxib Cyclooxygenase Inhibitors Enzyme Inhibitors Intestinal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms |