Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
Start Date
5/7/2021
Completion Date
5/1/2027
Summary
This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Gemcitabine
Oxaliplatin
Dexamethasone
Floxuridine (FUDR)
Implanted Medical Device
Conditions
Locations
National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)
Bethesda, Maryland 20824
United States
Washington University (Data Collection Only)
St Louis, Missouri 63110
United States
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth - Limited Protocol Activities
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen - Limited Protocol Activities
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Commack - Limited Protocol Activities
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester - Limited Protocol Activities
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Memorial Sloan Kettering Nassau - Limited Protocol Activities
Uniondale, New York 11553
United States
Duke University (Data Collection Only)
Durham, North Carolina 27710
United States
Erasmus University (Data Collection Only)
Rotterdam, 3015 GD
Netherlands