Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT00183859
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • irinotecan — DRUG
    Intraperitoneal Irinotecan given every three weeks

Study Details

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.

Key Dates

Start date
Sep 30, 1999
Status verified
May 2014
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

Enrollment
42 participants (actual)
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Intraperitoneal Irinotecan

Primary Outcome Measure

To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks. [ Time Frame: 6 weeks ]

Locations (1)

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

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