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NCT00183859 · ClinicalTrials.gov registry record · Phase 1

Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

A Phase 1 study, sponsored by University of Southern California.

Completed
Registry status
Phase 1
Development phase
42
Enrollment target

NCT00183859 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 42 participants.

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The verdict

NCT00183859, a Phase 1 study, has completed, sponsored by University of Southern California.

COMPLETED
Registry status
Phase 1
Development phase
42 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG irinotecan

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 1999-09
Est. Completion 2009-04
Phase Phase 1

Sponsor

University of Southern California

617 total trials

What the Registry Record Tells You About NCT00183859

The ClinicalTrials.gov registry entry for NCT00183859 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which irinotecan is the first listed.

NCT00183859 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00183859 about?

NCT00183859 is a clinical study titled "Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan". 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 irinote...

What is the current status of trial NCT00183859?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 1999-09. Estimated completion is 2009-04.

What interventions are being tested in trial NCT00183859?

The interventions under investigation include: irinotecan (DRUG).

Who is sponsoring clinical trial NCT00183859?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.