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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| 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 Condition |
Drug: Celecoxib Drug: Eflornithine Other: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| 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 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive oral celecoxib twice daily and oral placebo once daily.
|
Drug: Celecoxib
400 mg given orally
Other Name: Celebrex
Other: Placebo
Given orally once a day.
|
|
Experimental: Arm II
Patients receive celecoxib as in arm I and oral eflornithine once daily.
|
Drug: Celecoxib
400 mg given orally
Other Name: Celebrex
Drug: Eflornithine
0.5g/m2/day orally rounded down to the nearest 250 mg dose
Other Names:
|
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 |
Inclusion Criteria:
Exclusion Criteria:
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 | |
| 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: | Patrick M. Lynch, M.D., M. D. Anderson Cancer Center at University of Texas |
| ClinicalTrials.gov Identifier: | NCT00033371 History of Changes |
| Other Study ID Numbers: | ID00-109, P30CA016672, MDA-ID-00109, NCI-P02-0219, CDR0000069278 |
| Study First Received: | April 9, 2002 |
| Last Updated: | June 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
colon cancer rectal cancer familial adenomatous polyposis FAM precancerous condition |
|
Colorectal Neoplasms Disease Adenomatous Polyposis Coli Precancerous Conditions Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Pathologic Processes |
Adenomatous Polyps Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Colonic Neoplasms Neoplastic Syndromes, Hereditary Intestinal Polyposis Genetic Diseases, Inborn Eflornithine Celecoxib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |