Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial
- Evaluate time to progression of disease in patients with unresectable hepatocellular
carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization.
- Evaluate tumor response achievable with chemoembolization in this patient population.
- Evaluate the toxicities of this treatment in these patients.
- Evaluate survival of these patients following this treatment.
- Evaluate extrahepatic patterns of failure following chemoembolization, to determine
whether intrahepatic progression may be forestalled and survival affected in these
- Validate a consistent method of performing chemoembolization in a multicenter setting.
OUTLINE: Patients are stratified according to disease (hepatocellular carcinoma vs
neuroendocrine hepatic metastases).
Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin,
mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe
only. Immediately following delivery of the chemoemulsion, particulate embolization is
performed. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the
In the absence of unacceptable toxicity, each involved lobe is treated separately a second
time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization.
After completion of all protocol therapy, retreatment on study of either lobe is allowed for
regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the
initial treatment of that lobe.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study within 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression
Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions
Assessed every 3 months for 2 years, then every 6 months for 3 year.
Keith E. Stuart, MD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
|Veterans Affairs Medical Center - Atlanta (Decatur)||Decatur, Georgia 30033|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|Rush-Copley Cancer Care Center||Aurora, Illinois 60507|
|Hinsdale Hematology Oncology Associates||Hinsdale, Illinois 60521|
|Joliet Oncology-Hematology Associates, Limited - West||Joliet, Illinois 60435|
|Carle Cancer Center at Carle Foundation Hospital||Urbana, Illinois 61801|
|Saint Anthony Memorial Health Centers||Michigan City, Indiana 46360|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|St. Rita's Medical Center||Lima, Ohio 45801|
|Albert Einstein Cancer Center||Philadelphia, Pennsylvania 19141|
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|John Stoddard Cancer Center at Iowa Methodist Medical Center||Des Moines, Iowa 50309|
|Overlook Hospital||Summit, New Jersey 07902-0220|
|Carol G. Simon Cancer Center at Morristown Memorial Hospital||Morristown, New Jersey 07962|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Somerset Medical Center||Somerville, New Jersey 08876|
|Baptist Cancer Institute - Jacksonville||Jacksonville, Florida 32207|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Front Range Cancer Specialists||Fort Collins, Colorado 80528|
|Hematology Oncology Associates - Skokie||Skokie, Illinois 60076|
|Swedish Covenant Hospital||Chicago, Illinois 60625|
|Mercy Hospital and Medical Center||Chicago, Illinois 60616|
|Hematology and Oncology Associates||Chicago, Illinois 60611|
|Midwest Center for Hematology/Oncology||Joliet, Illinois 60432|
|North Shore Oncology and Hematology Associates, Limited - Libertyville||Libertyville, Illinois 60048|
|Hematology/Oncology of the North Shore at Gross Point Medical Center||Skokie, Illinois 60076|
|John Stoddard Cancer Center at Iowa Lutheran Hospital||Des Moines, Iowa 50316-2301|
|Mercy Capitol Hospital||Des Moines, Iowa 50307|
|Medical Oncology and Hematology Associates at John Stoddard Cancer Center||Des Moines, Iowa 50309|
|Medical Oncology and Hematology Associates at Mercy Cancer Center||Des Moines, Iowa 50314|
|Mercy Cancer Center at Mercy Medical Center - Des Moines||Des Moines, Iowa 50314|
|Medical Oncology and Hematology Associates - West Des Moines||West Des Moines, Iowa 50266|