A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer

November 30, 2016 updated by: Celgene Corporation

A Phase II, Randomized, Open-label, Controlled, Dose-elevation, Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer

The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer. The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy treatment is diarrhea. The purpose of this research study is to see whether adding this investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. This study will also determine if adding the investigational drug to triple therapy has a positive effect on tumors.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Center
    • California
      • Anaheim, California, United States, 92801
        • Research Center
      • Concord, California, United States, 94520
        • Research Center
      • Gilroy, California, United States, 95020
        • Research Center
      • Los Angeles, California, United States, 90057
        • Research Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Research Center
      • New Port Richey, Florida, United States, 34652
        • Research Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Research Center
    • Maine
      • Scarborough, Maine, United States, 04074-9308
        • Research Center
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Research Center
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Research Center
      • St. Joseph, Michigan, United States, 49085
        • Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Research Center
    • Missouri
      • St. Joseph, Missouri, United States, 64507
        • Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Research Center
    • New York
      • East Setauket, New York, United States, 11733
        • Research Center
      • Northport, New York, United States, 11768-2364
        • Research Center
    • North Carolina
      • Burlington, North Carolina, United States, 27216
        • Research Center
      • Greenville, North Carolina, United States, 27834
        • Research Center
    • Ohio
      • Zanesville, Ohio, United States, 43701
        • Research Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17605
        • Research Center
      • Philadelphia, Pennsylvania, United States, 19140-5189
        • Research Center
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Research Center
      • Charleston, South Carolina, United States, 29406
        • Research Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Research Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Research Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-2454
        • Research Center
      • Milwaukee, Wisconsin, United States, 53215
        • Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of colorectal cancer or adenocarcinoma of the appendix
  • A tumor mass that can be measured
  • Resolution of all toxic effects of any radiotherapy or surgical procedures to NCI CTC grade less than or equal to 1
  • Willingness and ability to comply with scheduled visits, treatment plan, and laboratory tests, and other study procedures

Exclusion Criteria:

  • Women that are pregnant or lactating
  • Prior treatment with Irinotecan
  • Partial or complete bowel obstruction, known chronic malabsorption, or total colectomy or other major abdominal surgery that might result in substantial alteration in transit or absorption of oral medication
  • Administration of the last dose of any previous adjuvant therapy for colorectal cancer within 6 months previous to randomization
  • Current enrollment in another clinical trial
  • Administration of any prior systemic anticancer therapy for metastatic colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

June 26, 2002

First Submitted That Met QC Criteria

June 26, 2002

First Posted (Estimate)

June 27, 2002

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 440E-ONC-0020-315

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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