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Brief Title: For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy
Official Title: Phase II, Randomized, Double-Blind, Multicenter Trial Of Celecoxib Vs Placebo For The Prevention Of Diarrhea Associated With CPT-11/5fu/LV Chemotherapy In Patients With Previously Untreated Metastatic Colorectal Cancer
Study ID: NCT00037180
Brief Summary: The Diarrhea Prevention with an investigational drug trial, will evaluate whether adding an investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5FU), and leucovorin (also known as LV). Preclinical data from animal models suggest that the investigational drug may offer an effective means for preventing CPT-11/5FU/LV-induced diarrhea. It is also hypothesized that the investigational drug-mediated anti-angiogenesis could induce a favorable tumor response.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Pfizer Investigational Site, Mobile, Alabama, United States
Pfizer Investigational Site, Ft. Lauderdale, Florida, United States
Pfizer Investigational Site, Port St. Lucie, Florida, United States
Pfizer Investigational Site, Chicago, Illinois, United States
Pfizer Investigational Site, St. Joseph, Missouri, United States
Pfizer Investigational Site, St. Louis, Missouri, United States
Pfizer Investigational Site, Buffalo, New York, United States
Pfizer Investigational Site, Williamsville, New York, United States
Pfizer Investigational Site, Altoona, Pennsylvania, United States
Pfizer Investigational Site, Puyallup, Washington, United States
Pfizer Investigational Site, Yakima, Washington, United States
Pfizer Investigational Site, Milwaukee, Wisconsin, United States
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR