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Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
U.S.C./Norris Cancer Center
Los Angeles, California, United States
Start Date
December 1, 2000
Primary Completion Date
October 1, 2007
Completion Date
July 1, 2009
Last Updated
May 22, 2014
22
ACTUAL participants
irinotecan
DRUG
radiation therapy
PROCEDURE
Lead Sponsor
University of Southern California
NCT05053971
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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