Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00503035 |
Primary Objective:
Condition | Intervention | Phase |
---|---|---|
Familial Adenomatous Polyposis |
Drug: Celecoxib Procedure: Colonoscopy Biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Molecular Targeting of 15-LOX-1 for Apoptosis Induction in Human Colorectal Cancers |
Estimated Enrollment: | 40 |
Study Start Date: | August 2003 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Celecoxib: Experimental |
Drug: Celecoxib
400 mg By Mouth Twice Daily x 6 Months
Procedure: Colonoscopy Biopsy
Up to 23 additional colon tissue biopsies (the size of a pencil tip), additional 20 minutes on colonoscopy procedure
|
Celecoxib is a drug that was developed to treat arthritis. However, celecoxib may also help to stop or slow the growth of colon and rectal tumor cells.
At the start of the study, you will be asked questions about your medical history, have a complete physical exam, and have around 2 tablespoons of blood drawn for blood tests as part of your routine care for familial adenomatous polyposis. Also, blood tests such as fasting blood glucose and lipid profiling (cholesterol, LDL, HDL and triglyceride) will be assessed to determine eligibility. Women who are able to have children must have a negative blood pregnancy test within 14 days of starting celecoxib.
Before your scheduled colonoscopy, you will fill out a form asking about any medications and nutritional supplements that you are taking. In addition, you will be asked to complete a diet history. This will help researchers to evaluate patients' dietary habits. The questionnaire takes about 15 minutes to complete. You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood. Then, during your already scheduled colonoscopy procedure, you will have additional tissue biopsies (the size of a pencil tip) of your colon taken. For a colonoscopy procedure, a flexible tube with a light attached to the end is used to look inside your colon/lower gut. The biopsies will be taken through the flexible tube using a special cutting tool.
Up to 23 biopsy samples may be taken. The biopsies should take about 20 extra minutes to complete.
After the procedure, you will start taking celecoxib by mouth once every 12 hours for 6 months. You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood at the completion of month 2 and 4 of celecoxib treatment. At the end of the 6 month treatment period, you will have another colonoscopy procedure. This is an additional procedure performed solely for this study and is not part of your standard of care for the treatment of familial adenomatous polyposis. A second set of biopsies will be taken (23 maximum).
These biopsy samples will be studied and compared to the samples taken before treatment with celecoxib. You will also have around 1 teaspoon of blood drawn to measure the amount of celecoxib in your blood.
You will be contacted by phone 72 hours after your first dose of celecoxib and then every 2 weeks for the study to check for any side effects you may be experiencing.
The maximum amount of time you will remain on this study is 6 months. If at any time, you experience any intolerable side effects, you will be taken off the study.
This is an investigational study. Celecoxib is FDA approved and commercially available for familial adenomatous polyposis patients to reduce polyp formation. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of familial adenomatous polyposis (patients should have colorectal remnant that can be biopsied.
Patients who have had total colorectal surgical resection are not eligible).
Women of childbearing potential (women are considered to be of childbearing potential unless they are at 2 or more years post-menopausal/or surgically sterile), must:
Exclusion Criteria:
Metabolic syndrome diagnosis in patients who are 30 years or older. (The diagnosis of metabolic syndrome is made when three or more of these risk factors are present):
Contact: Imad Shureiqi, MD | 713-745-4929 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Imad Shureiqi, MD |
Principal Investigator: | Imad Shureiqi, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Imad Shureiqi, MD/MS/Associate Professor ) |
Study ID Numbers: | DM02-592 |
Study First Received: | July 16, 2007 |
Last Updated: | May 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00503035 History of Changes |
Health Authority: | United States: Institutional Review Board |
Familial Adenomatous Polyposis Colorectal Tumors Molecular Targeting Celecoxib Celebrex SC-58635 |
Apoptosis Induction Colon Rectum colonoscopy Biopsy |
Anti-Inflammatory Agents Gastrointestinal Diseases Adenomatous Polyposis Coli Familial Adenomatous Polyposis Colonic Diseases Polyps Rectal Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Adenomatous Polyps Familial Polyposis Digestive System Neoplasms Celecoxib Cyclooxygenase Inhibitors |
Intestinal Diseases Intestinal Neoplasms Digestive System Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Antirheumatic Agents Adenoma Colonic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Adenomatous Polyposis Coli Physiological Effects of Drugs Colonic Diseases Rectal Diseases Neoplasms by Site Sensory System Agents 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 Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Antirheumatic Agents |