Trial Outcomes & Findings for A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy (NCT NCT00587067)

Last Updated: 2023-04-04

Results Overview

To assess the efficacy of continuous arterial infusion (HAI) of FUDR (Floxuridine) and dexamethasone (DEX) in patients with unresectable hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2023-04-04

Participant Flow

Protocol Open to Accrual 6/24/2003, Protocol Closed to Accrual 7/24/2007, Primary Completion Date 5/19/2016, Recruitment location is the medical clinic

Participant milestones

Participant milestones
Measure	Floxuridine + Dexamethasone 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.
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Floxuridine + Dexamethasone n=34 Participants 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.
Age, Continuous	56.5 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Floxuridine + Dexamethasone n=34 Participants Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
Treatment Response Stable Disease	14 Participants
Treatment Response Partial Response	16 Participants
Treatment Response Progression of Disease	4 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Toxicity evaluated and graded according to the National Cancer Institute, CTCAE v4.0

Outcome measures

Outcome measures
Measure	Floxuridine + Dexamethasone n=34 Participants Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
Number of Patients With Treatment Related Toxicity	34 participants

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Floxuridine + Dexamethasone n=34 Participants Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
Disease Progression PD in the liver, alone	18 Participants
Disease Progression PD in the liver and an extrahepatic location	3 Participants
Disease Progression PD initially at an extrahepatic site only	12 Participants
Disease Progression No PD	1 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Median Survival from Initiation of Hepatic Arterial Infusion

Outcome measures

Outcome measures
Measure	Floxuridine + Dexamethasone n=34 Participants Patients with hepatocellular carcinoma and peripheral cholangiocarcinoma, considered unresectable after review by the Hepatobiliary Surgery service will undergo hepatic artery pump placement and continuous infusion of Floxuridine.
Median Survival	29.3 months Interval 26.6 to 31.9

Adverse Events

Floxuridine + Dexamethasone

Serious events: 5 serious events

Other events: 5 other events

Deaths: 33 deaths

Serious adverse events

Serious adverse events
Measure	Floxuridine + Dexamethasone n=34 participants at risk 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.
Investigations Bilirubin Increased	5.9% 2/34 • 5 years
Gastrointestinal disorders GI, other	2.9% 1/34 • 5 years
Hepatobiliary disorders Hepatic, other	2.9% 1/34 • 5 years
Gastrointestinal disorders Melena	2.9% 1/34 • 5 years
General disorders Pain, other	2.9% 1/34 • 5 years

Other adverse events

Other adverse events
Measure	Floxuridine + Dexamethasone n=34 participants at risk 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.
Investigations Increased bilirubin	8.8% 3/34 • 5 years
Nervous system disorders Headache/Migraine	2.9% 1/34 • 5 years
Gastrointestinal disorders Diarrhea	2.9% 1/34 • 5 years
Infections and infestations Wound infection	8.8% 3/34 • 5 years
Psychiatric disorders Delerium	2.9% 1/34 • 5 years
Cardiac disorders Supraventricular tachycardia	2.9% 1/34 • 5 years

Additional Information

Dr. William Jarnagin, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-3624

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place