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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00258219 |
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may stop polyps from forming in patients with familial adenomatous polyposis.
PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with familial adenomatous polyposis.
Condition | Intervention |
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Colorectal Cancer Precancerous/Nonmalignant Condition |
Drug: celecoxib |
Study Type: | Interventional |
Study Design: | Prevention, Open Label |
Official Title: | Molecular Targeting of 15-LOX-1 for Apoptosis Induction in Human Colorectal Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | November 2002 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive oral celecoxib twice daily for 6 months.
Patients also undergo colonoscopy, including a total of 23 colorectal biopsies, once before and after treatment with celecoxib.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of familial adenomatous polyposis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No history of any of the following cardiovascular conditions:
No uncontrolled hypercholesteremia, defined as low-density lipoprotein cholesterol > 130 mg/dL
Pulmonary
Immunologic
Other
No metabolic syndrome, defined by ≥ 3 of the following risk factors:
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
Other
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Study Chair: | Imad Shureiqi, MD, MS | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000442104, MDA-DM-02592 |
Study First Received: | November 22, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00258219 |
Health Authority: | Unspecified |
colon cancer rectal cancer familial adenomatous polyposis |
Familial adenomatous polyposis Celecoxib Digestive System Neoplasms Precancerous Conditions Rectal Neoplasms Adenomatous Polyposis Coli Gastrointestinal Diseases Colonic Diseases Familial polyposis Polyps Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Rectal neoplasm Neoplastic Syndromes, Hereditary Digestive System Diseases Genetic Diseases, Inborn Gastrointestinal Neoplasms Rectal cancer Colonic Neoplasms Adenoma Colorectal Neoplasms Adenomatous Polyps Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Neoplasms by Histologic Type Intestinal Polyposis Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |