Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00183846
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2005-09-09
Brief Title:
Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers
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 study is for people with advanced cancer of the digestive tract and cancer that cannot be completely removed by surgery Radiation therapy is commonly used in the treatment of these types of cancer in combination with a chemotherapy drug called 5-fluorouracil 5-FU In this study doctors will administer the standard dose of radiation therapy in combination with an investigational chemotherapy drug called irinotecan Irinotecan can decrease the size of tumors and also appears to increase the effectiveness of radiation The purpose of this study is to determine the highest dose of irinotecan that can be given safely in combination with radiation therapy and to determine the side effects when these two treatments are given together Irinotecan is approved by the Food and Drug Administration FDA for the treatment of colon cancer but is not approved for cancers of the digestive tract However the FDA is allowing its use in this research study
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