A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

May 19, 2016

Study Completion Date

May 19, 2016

Conditions
Hepatic Cancer
Interventions
DRUG

FLOXURIDINE

"\[0.16\* mg/kg/day X 30 ml\] / pump flow rate~\* If the patient is \>25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles."

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
collaborator

Wake Forest University

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00587067 - A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy | Biotech Hunter | Biotech Hunter