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Sponsors and Collaborators: |
Norris Comprehensive Cancer Center Pfizer |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00183807 |
This study is for patients with cancer of the esophagus. This study uses the drugs irinotecan, cisplatin and celecoxib. Irinotecan (also known as CPT-11) was recently approved by the U.S. Food and Drug Administration (FDA) for use in colon cancer, but has not been approved by the FDA for use in the treatment of cancers of the esophagus. Cisplatin is a drug that is commonly used to treat patients with cancer of the esophagus. We are combining these two chemotherapy drugs with a drug called Celebrex. Celebrex (also called Celecoxib) is an oral medication that is approved by the FDA for pain in the treatment of arthritis. There is some information to suggest that this drug may have anti-cancer activity. In prior studies combining irinotecan and cisplatin, tumors of the esophagus have been shown to shrink. We are adding Celebrex to these drugs to see if it makes the drugs work better to shrink cancer or cause fewer side effects.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer |
Drug: irinotecan, cisplatin, celecoxib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Irinotecan (Camptosar), Cisplatin and Celebrex in Patients With Metastatic or Unresectable Esophageal Cancer |
Estimated Enrollment: | 65 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | February 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate renal function as documented by
1) creatinine less than or equal to 1.5 X institutional upper limit of normal OR 2) creatinine clearance > 60 mL/min as calculated with
Exclusion Criteria:
United States, California | |
U.S.C. / Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Syma Iqbal, M.D. | U.S.C./ Norris Comprehensive Cancer Center |
Study ID Numbers: | 3E-02-1 |
Study First Received: | September 9, 2005 |
Last Updated: | May 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00183807 |
Health Authority: | United States: Food and Drug Administration |
Celecoxib Digestive System Neoplasms Digestive System Diseases Cisplatin Esophageal disorder Gastrointestinal Diseases |
Head and Neck Neoplasms Esophageal Neoplasms Irinotecan Gastrointestinal Neoplasms Esophageal Diseases Esophageal neoplasm |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |