Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00183859
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2005-09-09
Brief Title:
Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None