LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed

Completed · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant.

Key facts

Study ID

NCT00877071

Run by

University of Pittsburgh

People needed

2

Starts

2008-11-01

Expected to finish

2012-04-01

Last updated by the study team

2016-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• HCC with gross vascular invasion or extrahepatic disease
• Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated > 3 years prior to entry is permitted
• Renal failure requiring dialysis
• Child-Pugh B9 or C hepatic impairment
• History of cardiac disease: NYHA class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
• Active clinically serious infections (> CTCAEv3 grade 2)
• Known history of HIV
• Known central nervous system tumors including metastatic brain disease
• History of organ allograft
• Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• Allergy to the investigational agents or any agent given in association with this trial.
• Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
• Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic blood pressure > 90mmHg
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
• Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
• Serious non-healing wound, ulcer, or bone fracture
• Any contraindication for doxorubicin administration:
• serum bilirubin > 3mg/dL
• WBC < 3000 cells/mm3
• neutrophil < 1500 cells/mm3
• cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or MRI
• MUGA scan < 40% ejection fraction
• Any contraindication for hepatic embolization procedures
• Excluded therapies and medications, previous and concomitant:

Where it is running

• UPMC Liver Cancer Center, Montefiore 7 South, 3459 Fifth Avenue — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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