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Monoclonal Antibodies
Floxuridine + Dexamethasone + Bevacizumab for Liver Cancer
Phase 2
Waitlist Available
Led By William R. Jarnagin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC)
Unresectable disease with less than 70% liver involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying floxuridine, dexamethasone, and bevacizumab to see how well they work in treating patients with unresectable primary liver cancer.
Who is the study for?
This trial is for patients with primary liver cancer that can't be removed by surgery. Eligible participants may have had previous chemotherapy, must not have a history of certain bleeding in the esophagus, and should not have more than 70% liver involvement or any spread outside the liver. They need measurable disease and good enough health to withstand anesthesia.Check my eligibility
What is being tested?
The study tests combining floxuridine and dexamethasone (chemotherapy drugs) given directly into the liver's arteries with bevacizumab (a monoclonal antibody). The goal is to see if this approach better kills tumor cells by blocking their blood supply and growth.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, increased risk of bleeding or wound healing complications, high blood pressure, damage to organs from blocked blood flow, fatigue, changes in blood counts leading to higher infection risk or bruising easily.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is either HCC or ICC, confirmed by tissue analysis.
Select...
My cancer cannot be surgically removed and involves less than 70% of my liver.
Select...
I can care for myself but may not be able to do active work.
Select...
I am eligible for surgery under general anesthesia and can have a liver pump placed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antitumor efficacy (complete and partial response, stable and progressive disease)
Secondary outcome measures
Toxicity as measured by NCI Common Toxicity Criteria
Side effects data
From 2013 Phase 2 trial • 28 Patients • NCT0115709189%
10020772-Hypertension
61%
10021038-Hyponatremia
57%
10016256-Fatigue
57%
10012727-Diarrhea
57%
10011368-Creatinine increased
57%
10047900-Weight loss
54%
10020949-Hypocalcemia
50%
10028813-Nausea
50%
10020943-Hypoalbuminemia
50%
10049182-White blood cell decreased
46%
10035528-Platelet count decreased
39%
10002272-Anemia
39%
10001675-Alkaline phosphatase increased
36%
10020647-Hyperkalemia
36%
10021005-Hypoglycemia
36%
10003481-Aspartate aminotransferase increased
36%
10025256-Lymphocyte count decreased
32%
10033371-Pain
32%
10002646-Anorexia
25%
10040752-Sinus tachycardia
25%
10003988-Back pain
25%
10000081-Abdominal pain
25%
10033425-Pain in extremity
21%
10019211-Headache
21%
10013573-Dizziness
21%
10047700-Vomiting
21%
10037032-Proteinuria
21%
10010774-Constipation
21%
10029366-Neutrophil count decreased
18%
10020870-Hypertriglyceridemia
18%
10003239-Arthralgia
18%
10001551-Alanine aminotransferase increased
18%
10005364-Blood bilirubin increased
18%
10047896-Weight gain
14%
10016766-Flatulence
14%
10040741-Sinus bradycardia
14%
10020639-Hyperglycemia
14%
10020680-Hypernatremia
14%
10021059-Hypophosphatemia
14%
10028411-Myalgia
14%
10056910-GGT increased
14%
10013963-Dyspnea
11%
10041349-Somnolence
11%
10013911-Dysgeusia
11%
10034620-Peripheral sensory neuropathy
11%
10020587-Hypercalcemia
11%
10016558-Fever
11%
10017577-Gait disturbance
11%
10021018-Hypokalemia
11%
10016750-Flank pain
11%
10002855-Anxiety
11%
10021097-Hypotension
11%
10062501-Non-cardiac chest pain
11%
10046300-Upper respiratory infection
11%
10062572-Generalized muscle weakness
7%
10024264-Lethargy
7%
10017853-Gastritis
7%
10015218-Erythema multiforme
7%
10019611-Hemorrhoids
7%
10038064-Rectal hemorrhage
7%
10038072-Rectal pain
7%
10033987-Paresthesia
7%
10020407-Hot flashes
7%
10040947-Skin ulceration
7%
10008531-Chills
7%
10050068-Edema limbs
7%
10016791-Flu like symptoms
7%
10021028-Hypomagnesemia
7%
10003246-Arthritis
7%
10006002-Bone pain
7%
10022437-Insomnia
7%
10040872-Skin infection
7%
10046571-Urinary tract infection
7%
10008661-Cholesterol high
7%
10055599-Hemoglobin increased
7%
10034263-Pelvic pain
7%
10011224-Cough
4%
10016825-Flushing
4%
hand-foot syndrome symptoms
4%
10037087-Pruritus
4%
10040868-Skin hypopigmentation
4%
10031009-Oral pain
4%
10041367-Sore throat
4%
10038062-Rectal fistula
4%
10023424-Kidney infection
4%
hand-foot syndrome
4%
10047681-Voice alteration
4%
10028130-Mucositis oral
4%
10034474-Pericardial effusion
4%
10069339-Acute kidney injury
4%
10012174-Dehydration
4%
10042112-Stomach pain
4%
10001760-Alopecia
4%
10013786-Dry skin
4%
10033557-Palpitations
4%
10037868-Rash maculo-papular
4%
urothelial carcinoma
4%
10020670-Hypermagnesemia
4%
10029883-Obesity
4%
10054520-Oral dysesthesia
4%
10066874-Gastroesophageal reflux disease
4%
10051272-Facial muscle weakness
4%
piriformis syndrome
4%
10019450-Hematuria
4%
10046539-Urinary frequency
4%
10046555-Urinary retention
4%
10046628-Urine discoloration
4%
10061574-Urinary tract obstruction
4%
aortic sclerosis w/o significant stenosis, mitral annular calcification
4%
10005886-Blurred vision
4%
10002167-Anal pain
4%
10005265-Bloating
4%
10009887-Colitis
4%
10013781-Dry mouth
4%
10062466-Localized edema
4%
10040753-Sinusitis
4%
10061229-Lung infection
4%
bacterial infection
4%
10016173-Fall
4%
10028836-Neck pain
4%
10031282-Osteoporosis
4%
10048677-Buttock pain
4%
10048706-Joint range of motion decreased
4%
10065895-Muscle weakness upper limb
4%
Joint effusion with extensive nodular synovial proliferation
4%
10062225-Urinary tract pain
4%
10046904-Vaginal dryness
4%
10046916-Vaginal inflammation
4%
10028735-Nasal congestion
4%
10036790-Productive cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I
Trial Design
1Treatment groups
Experimental Treatment
Group I: UNRESECTABLE PRIMARY HEPATIC MALIGNANCYExperimental Treatment10 Interventions
All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Dexamethasone
FDA approved
Floxuridine
FDA approved
protein expression analysis
2005
Completed Phase 2
~1080
dynamic contrast-enhanced magnetic resonance imaging
2006
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,870 Total Patients Enrolled
20 Trials studying Liver Cancer
7,791 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,292 Total Patients Enrolled
104 Trials studying Liver Cancer
27,006 Patients Enrolled for Liver Cancer
William R. Jarnagin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no cancer other than possibly skin cancer that hasn't spread.I don't take daily NSAIDs that affect blood clotting.I do not have any serious wounds, ulcers, or unhealed bone fractures.I do not have any bleeding disorders.I have not had radiation therapy targeting my liver.I have not used any clot-dissolving drugs recently.I am not scheduled for any major surgeries.My cancer is either HCC or ICC, confirmed by tissue analysis.My cancer cannot be surgically removed and involves less than 70% of my liver.I can care for myself but may not be able to do active work.I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.I haven't had any cancer except for skin cancer in the last 5 years.I have never had bleeding from enlarged veins in my esophagus or stomach.I do not have fluid buildup in my abdomen.My cancer has not spread to my brain or other parts of my body.I haven't had any major abdominal issues like fistulas, perforations, or abscesses in the last 6 months.I don't take more than 325 mg of aspirin daily.I have had chemotherapy or ablative therapy before, but it didn't work.My blood clotting time is normal or controlled on warfarin.I am eligible for surgery under general anesthesia and can have a liver pump placed.I don't have any health conditions that would stop me from joining the study.I have mild chronic hepatitis or cirrhosis.I do not have any major heart problems.I have never been treated with floxuridine.
Research Study Groups:
This trial has the following groups:- Group 1: UNRESECTABLE PRIMARY HEPATIC MALIGNANCY
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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