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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT00183846
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • irinotecan — DRUG
  • radiation therapy — PROCEDURE

Study Details

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.

Key Dates

Start date
Dec 31, 2000
Status verified
May 2014
Primary completion
Oct 31, 2007
Completion
Jul 31, 2009

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

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)

Locations (1)

FacilityCityStateZIPSite coordinators
U.S.C./Norris Cancer CenterLos AngelesCalifornia90033-

Find similar trials in Los Angeles, CA

By condition
Gastric cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
U.S.C./Norris Cancer Center· Los Angeles, CA

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