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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00040391
Recruitment Status : Terminated
First Posted : June 27, 2002
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):
Celgene Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Diarrhea Drug: Investigational drug Drug: Irinotecan Drug: 5-fluorouracil Drug: Leucovorin Phase 2

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00040391

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

Responsible Party: Celgene Corporation Identifier: NCT00040391     History of Changes
Other Study ID Numbers: 440E-ONC-0020-315
First Posted: June 27, 2002    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Celgene Corporation:

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs