Spots Global Cancer Trial Database for A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
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Trial Identification
Brief Title: 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: 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 ID: NCT00040391
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Center, Little Rock, Arkansas, United States
Research Center, Anaheim, California, United States
Research Center, Concord, California, United States
Research Center, Gilroy, California, United States
Research Center, Los Angeles, California, United States
Research Center, Jacksonville, Florida, United States
Research Center, New Port Richey, Florida, United States
Research Center, New Orleans, Louisiana, United States
Research Center, Scarborough, Maine, United States
Research Center, Pittsfield, Massachusetts, United States
Research Center, East Lansing, Michigan, United States
Research Center, St. Joseph, Michigan, United States
Research Center, Minneapolis, Minnesota, United States
Research Center, St. Joseph, Missouri, United States
Research Center, Las Vegas, Nevada, United States
Research Center, East Setauket, New York, United States
Research Center, Northport, New York, United States
Research Center, Burlington, North Carolina, United States
Research Center, Greenville, North Carolina, United States
Research Center, Zanesville, Ohio, United States
Research Center, Lancaster, Pennsylvania, United States
Research Center, Philadelphia, Pennsylvania, United States
Research Center, Charleston, South Carolina, United States
Research Center, Charleston, South Carolina, United States
Research Center, Germantown, Tennessee, United States
Research Center, Dallas, Texas, United States
Research Center, Madison, Wisconsin, United States
Research Center, Milwaukee, Wisconsin, United States
Contact Details
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