Status:
COMPLETED
LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Biocompatibles UK Ltd
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 l...
Detailed Description
LC BeadTM is a new product specifically designed for TACE. LC BeadTM microspheres can be loaded with doxorubicin (Trade name: adriamycin), a chemotherapeutic anthracycline glycolide agent widely accep...
Eligibility Criteria
Inclusion
- Adults patients (≥ 18 years of age) with a diagnosis of HCC that is not amenable to surgical resection or local ablative therapy
- Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2cm with typical vascular features or AFP \> 200
- Patient must have one lesion \< 8cm or up to five lesions with total diameter \< 8cm
- Quantifiable disease limited to the liver; 40% of liver must be free of tumor burden
- Patient must have at least one tumor lesion that meets both of the following criteria:
- Lesion can be accurately measured in at least one dimension according to RECIST criteria
- Lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- ECOG performance status ≤ 2
- No prior systemic chemotherapy
- At least 4 weeks since prior TACE or interferon
- Not pregnant
- No significant baseline liver dysfunction. Child-Pugh class A and B 7-8 (in abscence of ascites)
- No significant renal impairment (creatinine clearance \< 30mL/minute) or patients on dialysis
- No current infections requiring antibiotic therapy
- Not on anticoagulation or suffering from a known bleeding disorder
- No unstable coronary artery disease or recent MI
- The following laboratory parameters
- Hemoglobin ≥ 8.5g/dL
- Total bilirubin ≤ 3.0mg/dL
- ALT and AST ≤ 5x upper limit of normal
- Serum creatinine ≤ 1.5x upper limit of normal
- INR ≤ 1.5 or a PT/PTT within normal limits
- Platelet count ≥ 50,000/uL
- Ability to understand the protocol and to agree to and sign a written informed consent document
- Exclusion Criteria:
- 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:
- Prior use of any systemic anti-cancer chemotherapy for HCC
- Prior use of any systemic investigational agents for HCC
- Major surgery within 6 weeks of start of study drug
- Radiotherapy during study or within 3 weeks prior to start of study drug
- Use of biological response modifiers such as granulocyte colony-stimulating factor (G-CSF)within 3 weeks prio to study entry
- Autologous bone marrow transplant or stem cell rescue within four months of study drug initiation
- Concomitant treatment with rifampin or St. John's wort
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00877071
Start Date
November 1 2008
End Date
April 1 2012
Last Update
March 11 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UPMC Liver Cancer Center, Montefiore 7 South, 3459 Fifth Avenue
Pittsburgh, Pennsylvania, United States, 15213