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Sponsors and Collaborators: |
University Health Network, Toronto Ontario Cancer Research Network Princess Margaret Hospital, Canada |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00188565 |
Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30% of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while reducing treatment toxicity remains one of the principal goals of therapy for patients with locally advanced rectal carcinoma. Treatment strategies that achieve this goal will have a significant impact on our society.C linical trials have shown that this type of cancer is less likely to come back if chemotherapy and radiotherapy are added to surgery. A combination of all three types of therapy is now standard.
Celecoxib (Celebrex®) is a drug that lessens the action of an enzyme called cyclooxygenase-2 (COX-2) also known as a "COX-2 inhibitor". It is an anti-inflammatory capsule (drug that reduces irritation) that is commonly used to treat arthritis. It is not a chemotherapy drug. Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer effect of radiotherapy, without increasing radiation side effects. This has not yet been confirmed in humans.The main purpose of this study is to confirm that celecoxib does not increase the side effects when given with radiotherapy and chemotherapy for rectal cancer. We shall also be looking at how effective the combination of radiotherapy, chemotherapy and celecoxib is in shrinking rectal cancer.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: Celecoxib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Trial of Celecoxib With Preoperative Chemoradiation for Resectable Rectal Cancer With In Vivo Analysis of Celecoxib Effector Pathways |
Estimated Enrollment: | 39 |
Study Start Date: | March 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John Kim, MD | 416-946-2126 | john.kim@rmp.uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: John Kim, MD 416-946-2126 john.kim@rmp.uhn.on.ca | |
Principal Investigator: John Kim, MD |
Principal Investigator: | John Kim, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | UHN REB 02-0130-C, Ontario Cancer ResearchNetwork |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00188565 |
Health Authority: | Canada: Ethics Review Committee |
Digestive System Neoplasms Celecoxib Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs 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 |