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

This study has been terminated.
Information provided by:
ClinicalTrials.gov Identifier:
First received: June 26, 2002
Last updated: March 13, 2007
Last verified: March 2007
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 Intervention Phase
Colorectal Neoplasms
Drug: Investigational drug
Drug: Irinotecan
Drug: 5-fluorouracil
Drug: Leucovorin
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Celgene:


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040391

  Show 28 Study Locations
Sponsors and Collaborators
Celgene Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00040391     History of Changes
Other Study ID Numbers: 440E-ONC-0020-315 
Study First Received: June 26, 2002
Last Updated: March 13, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene:

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

ClinicalTrials.gov processed this record on May 26, 2016