Clinical Trial: Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Study of Irinotecan Administered as a Continuous Infusion and Radiation Therapy for Upper Gastrointestinal Cancers

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 Summary:
Sponsor: University of Southern California

Current Primary Outcome: To determine the maximum tolerated dose of irinotecan when administered as a 5-day continuous infusion with concomitant radiation therapy in patients with upper gastrointestinal tumors (pancreas, stomach, duodenum, and common bile duct)

Original Primary Outcome: To determine the maximum tolerated dose of irinotecan when administered as a 5-day continuous infusion with concomitant radiation therapy in patients with upper gastrointestinal tumors (pancreas, stomach, duodenum, and common bile duct).

Current Secondary Outcome:

  • To describe the toxicity profile observed with this combination
  • To obtain preliminary information related to the efficacy of this combination


Original Secondary Outcome:

  • To describe the toxicity profile observed with this combination.
  • To obtain preliminary information related to the efficacy of this combination.


Information By: University of Southern California

Dates:
Date Received: September 9, 2005
Date Started: December 2000
Date Completion:
Last Updated: May 20, 2014
Last Verified: May 2014