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Sponsored by: |
University of Michigan Cancer Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00230399 |
This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer.
Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: Celecoxib Drug: Capecitabine Drug: Irinotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | C-2424: Phase II Study of Celecoxib, Capecitabine, and Irinotecan in Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 15 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Minimum indicator lesion size as follows:
Greater than or equal to 20 mm measured by conventional CT Greater than or equal to 10 mm measured by spiral techniques
Exclusion Criteria:
United States, Michigan | |
University of Michigan Cancer Center | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Mark Zalupski, M.D. | University of Michigan Cancer Center |
Responsible Party: | University of Michigan Comprehensive Cancer Center ( Dr. Mark Zalupski ) |
Study ID Numbers: | UMCC 3-24 |
Study First Received: | September 9, 2005 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00230399 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Anti-Inflammatory Agents Capecitabine Digestive System Neoplasms Celecoxib Gastrointestinal Diseases Cyclooxygenase Inhibitors Colonic Diseases Irinotecan Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Irinotecan Colonic Diseases Rectal Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Capecitabine Celecoxib Digestive System Neoplasms Cyclooxygenase Inhibitors Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |