Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of Southern California
- Study ID
- NCT00183859
- Phase
- PHASE1
- Status
- Completed
Conditions
- Adenocarcinoma
- Gastric Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- irinotecan — DRUGIntraperitoneal Irinotecan given every three weeks
Study Details
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.
Key Dates
- Start date
- Sep 30, 1999
- Status verified
- May 2014
- Primary completion
- Apr 30, 2009
- Completion
- Apr 30, 2009
Study Design
- Enrollment
- 42 participants (actual)
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: AIntraperitoneal Irinotecan
Primary Outcome Measure
To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks. [ Time Frame: 6 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| U.S.C. / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | - |
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