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.

Sponsor:

Collaborator:

Pfizer

Information provided by:

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00040391

First received: June 26, 2002

Last updated: March 13, 2007

Last verified: March 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	June 26, 2002
Last Updated Date	March 13, 2007
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00040391 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Colorectal Neoplasms Diarrhea
Intervention ^ICMJE	Drug: Investigational drug Drug: Irinotecan Drug: 5-fluorouracil Drug: Leucovorin
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00040391
Other Study ID Numbers ^ICMJE	440E-ONC-0020-315
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Celgene Corporation
Collaborators ^ICMJE	Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	Celgene Corporation
Verification Date	March 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top