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Completed Phase 1 Interventional

Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

ClinicalTrials.gov ID: NCT00183859

Public ClinicalTrials.gov record NCT00183859. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 8:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00183859
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
42 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 1999
Primary completion
Mar 31, 2009
Completion
Mar 31, 2009
Last update posted
May 21, 2014

1999 – 2009

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
U.S.C. / Norris Comprehensive Cancer Center Los Angeles California 90033

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00183859, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 21, 2014 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00183859 live on ClinicalTrials.gov.

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