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Sponsors and Collaborators: |
University of Michigan Cancer Center Eli Lilly and Company Barbara Ann Karmanos Cancer Institute |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00176813 |
This study will examine an investigational (experimental) treatment using gemcitabine, cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may be effective in reducing the size of cancerous tumors and/or preventing further tumor growth.
This is a phase II clinical trial studying the reactions of the patient's body and their tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. This study will also look at what kind of side effects this experimental treatment causes and see how often these side effects occur. Blood levels of celecoxib will be measured to find out how this treatment affects factors (proteins) involved in new blood vessel formation and tumor growth (angiogenesis).
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: Gemcitabine Drug: Cisplatin Drug: Celecoxib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer |
Enrollment: | 5 |
Study Start Date: | March 2003 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2003 (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
Exclusion Criteria
United States, Michigan | |
University of Michigan | |
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 2001-071, C2442 |
Study First Received: | September 9, 2005 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00176813 |
Health Authority: | United States: Food and Drug Administration |
Celecoxib Digestive System Diseases Digestive System Neoplasms Cisplatin Pancreatic Neoplasms Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |