Status:
COMPLETED
Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kill...
Detailed Description
OBJECTIVES: * Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular carcinoma. OUTLI...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification
- No advanced disease, as defined by any of the following:
- Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following:
- Vascular invasion, including segmental portal obstruction
- Extrahepatic spread
- Cancer-related symptoms (PST of 1-2)
- BCLC class D disease, as defined by the following:
- Okuda stage III disease
- World Health Organization (WHO) performance status 3 or 4
- Diffuse HCC, defined as massive ill-defined tumor involvement
- Child-Pugh Class C
- Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies)
- No significant liver decompensation
- Preserved liver function (Child-Pugh class A-B)
- No ascites (trace ascites allowed)
- No other active primary tumor
- Arteries supplying the lesion must be large enough to accept GelSpheres™ beads
- PATIENT CHARACTERISTICS:
- Bilirubin ≤ 3 mg/dL
- Albumin \> 2.0 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
- No active gastrointestinal bleeding
- No encephalopathy
- No contraindication to hepatic embolization procedures, as indicated by any of the following:
- Porto-systemic shunt
- Hepatofugal blood flow
- Platelet count \< 50,000/mm\^3
- International normalized ratio (INR) ≥ 1.8
- Partial thromboplastin time (PTT) ≥ 39 seconds
- Renal failure
- Severe atheromatosis
- No contraindication to doxorubicin hydrochloride administration, as indicated by any of the following:
- Bilirubin \> 5 mg/dL
- White blood cell (WBC) \< 1,500/mm\^3
- Ejection fraction \< 50% by isotopic ventriculography or echocardiography
- Not pregnant
- No known allergy to contrast media
- No intolerance to occlusion procedures
- No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:
- Active or risk of hemorrhage
- Patent extra-to-intracranial anastomoses or shunts
- End arteries leading directly to the cranial nerves
- Feeding arteries smaller than distal branches from which they emerge
- Collateral vessel pathways that would potentially endanger normal territories during embolization
- PRIOR CONCURRENT THERAPY:
- No prior anticancer therapy for HCC
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00293397
Start Date
November 1 2005
End Date
April 1 2011
Last Update
July 18 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410