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Sponsored by: |
Norris Comprehensive Cancer Center |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00183859 |
This is a research study for patients that have an advanced cancer that is confined mostly to the abdominal cavity and have failed treatment with conventional therapy, or for which no standard treatment exists. The purpose of this study is to determine the dose of a chemotherapy drug (called irinotecan) that can be administered safely into the abdominal cavity. We also wish to identify the side effects of irinotecan when it is administered directly into the abdomen. In this study, we will also determine the levels of irinotecan in the blood and in the abdominal cavity.
Irinotecan is a chemotherapy drug that can decrease the size of several different tumors. It is approved by the FDA for the treatment of colon cancer. It appears that some other chemotherapy drugs are more effective and may have less side effects when they are administered directly into the abdomen.
Condition | Intervention | Phase |
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Adenocarcinoma Gastric Cancer |
Drug: irinotecan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan |
Estimated Enrollment: | 25 |
Study Start Date: | September 1999 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Intraperitoneal Irinotecan
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Drug: irinotecan
Intraperitoneal Irinotecan given every three weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sarah E Cole, M.S. | 323-865-0820 | scole@ccnt.usc.edu |
United States, California | |
U.S.C. / Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Sarah E Cole, M.S. 323-865-0820 scole@ccnt.usc.edu |
Principal Investigator: | Syma Iqbal, M.D. | U.S.C. / Norris Comprehensive Cancer Center |
Responsible Party: | U.S.C./Norris Comprehensive Cancer Center ( Syma Iqbal, M.D. ) |
Study ID Numbers: | 0C-99-7 |
Study First Received: | September 9, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00183859 |
Health Authority: | United States: Food and Drug Administration |
solid tumor phase I phase one |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms Irinotecan |
Gastrointestinal Neoplasms Stomach cancer Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |