NCT00183859

Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Adenocarcinoma
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	irinotecan	Intraperitoneal Irinotecan given every three weeks

Timeline

• Start date: 1999-09-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2005-09-16
• Last updated: 2014-05-22

Locations

1 site across 1 country: United States