Spots Global Cancer Trial Database for Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6
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Trial Identification
Brief Title: Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6
Official Title: A Prospective, Randomized, Open-label Trial Comparing OnDose® AUC Optimized 5-FU Based Administration Versus Standard Body Surface Area (BSA) Dosing in Metastatic Colorectal Cancer Patients (mCRC) Treated With mFOLFOX6
Study ID: NCT01468623
Conditions
Study Description
Brief Summary: The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU versus standard Body Surface Area (BSA) based administration of 5-FU in patients with metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR) relative to BSA dosing response.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Birmingham, Alabama, United States
, Corona, California, United States
, Fountain Valley, California, United States
, La Jolla, California, United States
, Modesto, California, United States
, Rancho Cucamonga, California, United States
, Riverside, California, United States
, Santa Rosa, California, United States
, Washington, District of Columbia, United States
, Merritt Island, Florida, United States
, Ocala, Florida, United States
, Titusville, Florida, United States
, Viera, Florida, United States
, Albany, Georgia, United States
, Chicago, Illinois, United States
, Crystal Lake, Illinois, United States
, Galesburg, Illinois, United States
, Grayslake, Illinois, United States
, Highland Park, Illinois, United States
, Lake Forest, Illinois, United States
, Libertyville, Illinois, United States
, Niles, Illinois, United States
, Skokie, Illinois, United States
, Munster, Indiana, United States
, Louisville, Kentucky, United States
, Baton Rouge, Louisiana, United States
, Metairie, Louisiana, United States
, Ann Arbor, Michigan, United States
, Detroit, Michigan, United States
, Farmington Hills, Michigan, United States
, Great Falls, Montana, United States
, Las Vegas, Nevada, United States
, Hackensack, New Jersey, United States
, Johnson City, New York, United States
, Greensboro, North Carolina, United States
, Fargo, North Dakota, United States
, Minot, North Dakota, United States
, Canton, Ohio, United States
, Columbus, Ohio, United States
, Bend, Oregon, United States
, Drexel Hill, Pennsylvania, United States
, Philadelphia, Pennsylvania, United States
, Crossville, Tennessee, United States
, Huntsville, Tennessee, United States
, Bedford, Texas, United States
, Garland, Texas, United States
, Grapevine, Texas, United States
, Kerrville, Texas, United States
, McAllen, Texas, United States
, San Antonio, Texas, United States
, Tyler, Texas, United States
, Waco, Texas, United States
, Ogden, Utah, United States
, Salt Lake City, Utah, United States
, Fairfax, Virginia, United States
, Newport News, Virginia, United States
, Edmonds, Washington, United States
, Seattle, Washington, United States
Contact Details
Name: Abebe Haregewoin, MD, PhD
Affiliation: Myriad Genetic Laboratories, Inc.
Role: STUDY_DIRECTOR
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