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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 below

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My cancer is either HCC or ICC, confirmed by tissue analysis.

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My cancer cannot be surgically removed and involves less than 70% of my liver.

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I can care for myself but may not be able to do active work.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 • NCT01157091

89%

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

10017853-Gastritis

10015218-Erythema multiforme

10024264-Lethargy

10019611-Hemorrhoids

10038064-Rectal hemorrhage

10038072-Rectal pain

10033987-Paresthesia

10020407-Hot flashes

10040947-Skin ulceration

10008531-Chills

10050068-Edema limbs

10016791-Flu like symptoms

10021028-Hypomagnesemia

10003246-Arthritis

10006002-Bone pain

10022437-Insomnia

10040872-Skin infection

10046571-Urinary tract infection

10008661-Cholesterol high

10055599-Hemoglobin increased

10034263-Pelvic pain

10011224-Cough

10028130-Mucositis oral

10031009-Oral pain

10037087-Pruritus

hand-foot syndrome symptoms

10016825-Flushing

10041367-Sore throat

10040868-Skin hypopigmentation

10034474-Pericardial effusion

hand-foot syndrome

10038062-Rectal fistula

10023424-Kidney infection

10047681-Voice alteration

10069339-Acute kidney injury

10012174-Dehydration

10042112-Stomach pain

10001760-Alopecia

10013786-Dry skin

10033557-Palpitations

10037868-Rash maculo-papular

urothelial carcinoma

10020670-Hypermagnesemia

10029883-Obesity

10054520-Oral dysesthesia

10066874-Gastroesophageal reflux disease

10051272-Facial muscle weakness

piriformis syndrome

10019450-Hematuria

10046539-Urinary frequency

10046555-Urinary retention

10046628-Urine discoloration

10061574-Urinary tract obstruction

aortic sclerosis w/o significant stenosis, mitral annular calcification

10005886-Blurred vision

10002167-Anal pain

10005265-Bloating

10009887-Colitis

10013781-Dry mouth

10062466-Localized edema

10040753-Sinusitis

10061229-Lung infection

bacterial infection

10016173-Fall

10028836-Neck pain

10031282-Osteoporosis

10048677-Buttock pain

10048706-Joint range of motion decreased

10065895-Muscle weakness upper limb

Joint effusion with extensive nodular synovial proliferation

10062225-Urinary tract pain

10046904-Vaginal dryness

10046916-Vaginal inflammation

10028735-Nasal congestion

10036790-Productive cough

100%

80%

60%

40%

20%

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

~1100

dynamic contrast-enhanced magnetic resonance imaging

2006

Completed Phase 2

~450

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,565 Total Patients Enrolled

20 Trials studying Liver Cancer

7,791 Patients Enrolled for Liver Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,098 Total Patients Enrolled

103 Trials studying Liver Cancer

26,613 Patients Enrolled for Liver Cancer

William R. Jarnagin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00410956 — Phase 2

Liver Cancer Research Study Groups: UNRESECTABLE PRIMARY HEPATIC MALIGNANCY

Liver Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT00410956 — Phase 2

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00410956 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to partake in this research?

"Individuals with liver neoplasms and between the ages of 18-120 can participate in this medical trial, which is accepting 55 participants."

Answered by AI

How many participants have been selected to take part in this trial?

"Unfortunately, this study is no longer searching for patients. It was posted on May 1st 2007 and edited last August 9th 2022. Nevertheless, there are still 251 clinical trials looking to enroll individuals with liver neoplasms and an additional 915 studies that focus on immunologic techniques actively recruiting participants."

Answered by AI

Are there additional clinical experiments employing immunologic processes?

"Currently, there are 915 active clinical trials examining immunologic approaches. Of these experiments, 236 have reached the third stage of research and most can be found in Mishawaka, Indiana; however, across 35636 locations worldwide studies regarding immunology remain ongoing."

Answered by AI

Is this exploration still open to enrollment?

"This clinical trial is no longer available for enrollment. It was initially posted on May 1st 2007 and last updated 8/9/2022. Those interested in similar studies can explore 251 other trials involving liver neoplasms, or 915 related to immunologic technique currently recruiting patients."

Answered by AI

Are there potential health risks associated with immunologic treatments?

"Our experts at Power rate the safety of this immunologic technique a 2 on our scale, as data confirms its security but there is limited information available regarding effectiveness."

Answered by AI

Does this investigation accept participants over the age of forty?

"To be considered for this medical experiment, the participants must range from 18-120 years of age. Additionally, there are 114 trials that only accept applicants aged under 18 and 1073 studies available to those over 65."

Answered by AI

What does immunologic technique typically accomplish?

"Synovitis can be managed through immunologic technique, which has also been used to help those suffering from ophthalmia, sympathetic inflammation, branch retinal vein occlusion and macular edema."

Answered by AI

Recent research and studies

OncologyJournal

Treating Primary Liver Cancer with Hepatic Arterial Infusion of Floxuridine and Dexamethasone: Does the Addition of Systemic Bevacizumab Improve Results

Kemeny, Nancy E., Lawrence Schwartz, Mithat Gönen, Adam Yopp, David Gultekin, Michael I. D’Angelica, Yuman Fong, et al.. 2011. “Treating Primary Liver Cancer with Hepatic Arterial Infusion of Floxuridine and Dexamethasone: Does the Addition of Systemic Bevacizumab Improve Results”. Oncology. S. Karger AG. doi:10.1159/000324704.

clinicaltrials.govStudy

Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery

2007. "Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00410956.

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