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| Sponsor: | USC/Norris Comprehensive Cancer Center |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00183807 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00183807 History of Changes |
| Other Study ID Numbers: | 3E-02-1 |
| Study First Received: | September 9, 2005 |
| Last Updated: | May 5, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Irinotecan Cisplatin Celecoxib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents |