Phase 2 N=22 Treatment

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

Liver Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00410956 ↗

Enrolled (actual)

Serious AEs

54.6%

Results posted

Dec 2024

Primary outcome: Primary: Median Overall Survival — 31.1 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bevacizumab (Biological); dexamethasone (Drug); floxuridine (Drug); protein expression analysis (Genetic); flow cytometry (Other); immunoenzyme technique (Other); immunohistochemistry staining method (Other); immunologic technique (Other); laboratory biomarker analysis (Other); dynamic contrast-enhanced magnetic resonance imaging (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Overall Survival	31.1	—
PRIMARY Median Hepatic Progression Free Survival	11.28	—
PRIMARY Median Progression Free Survival	8.45	—
PRIMARY Antitumor Efficacy (Complete and Partial Response, Stable and Progressive Disease)	7; 15	—
SECONDARY Number of Participants Evaluated for Toxicity as Measured by NCI Common Toxicity Criteria	22	—

Summary

RATIONALE: Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy directly into the arteries around the tumor together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving floxuridine and dexamethasone as a hepatic arterial infusion together with bevacizumab works in treating patients with unresectable primary liver cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC)
Peripheral, cholangiolar, or cholangiocellular types
Mixed HCC/ICC disease allowed
Unresectable disease
Less than 70% liver involvement
Radiographically bidimensionally measurable disease, defined as lesion ≥ 2 cm in the greatest diameter
May have failed prior systemic chemotherapy or ablative therapy
No radiographic evidence of esophageal varices
No history of variceal hemorrhage
No occlusion of the main portal vein or the right and left portal branches
No clinical ascites
Patients ineligible for first-line MSKCC protocols for HCC are eligible for this study provided there is no clinical or radiographic evidence of extrahepatic disease
No metastatic disease, including CNS metastases

PATIENT CHARACTERISTICS:

Life expectancy ≥ 12 weeks
Karnofsky performance status 60-100%
Considered a candidate for general anesthesia and hepatic artery pump placement
Platelet count > 100,000/mm³
Albumin > 2.5 g/dL
Bilirubin 3,500/mm³
PTT 150 mm Hg or diastolic BP > 100 mm Hg on antihypertensive medications
New York Heart Association class II-IV congestive heart failure
Vascular disease (e.g., aortic aneurysm, aortic dissection)
Myocardial infarction within the past 6 months
Symptomatic peripheral vascular disease
Unstable angina within the past 6 months
History of hypertensive crisis
Transient ischemic attack
Stroke
No other concurrent malignancy except localized basal cell or squamous cell skin cancer
Chronic hepatitis and/or cirrhosis allowed provided it is Child-Pugh class A disease
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 4 weeks since prior and no other concurrent experimental therapy except on a Genentech-sponsored bevacizumab cancer study
More than 4 weeks since prior major surgical procedure or open biopsy
More than 1 week since prior minor surgical procedure (e.g., core biopsy), excluding placement of a vascular access device
No prior external-beam radiation therapy to the liver
No prior floxuridine
No chronic daily treatment with nonsteroidal anti-inflammatory medications known to inhibit platelet function
No chronic daily treatment with aspirin (> 325 mg/day)
No concurrent or recent use of a thrombolytic agent
No concurrent major surgery

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00410956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.