RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and
keeping chemotherapy drugs near the tumor.
PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients
who have primary liver cancer or metastases to the liver that cannot be surgically removed.
- 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 extrahepatic patterns of failure following chemoembolization, to determine
whether intrahepatic progression may be forestalled and survival affected in these
patients.
- 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
initial lobe.
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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor.
- Unresectable.
- Bidimensionally measurable disease by Computed Tomography (CT), Magnetic resonance
imaging (MRI), or UltraSound Scanning (US) within 6 weeks of registration.
- Evidence of patent portal vasculature by Doppler US, MRI, or angiography.
- Serum total bilirubin < 2. 0 mg/dl and serum creatinine < 2. 0 mg/dl within 4 weeks of
registration.
- Absolute neutrophil count (ANC) > 2000/µl and platelets > 50,000/µl within 4 weeks of
registration.
- Expected survival of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age >= 18 years.
Exclusion Criteria:
- Evidence of extrahepatic disease that is likely to be life-threatening within 3
months, such as brain or symptomatic lung metastases.
- Previous intra-arterial or intra-hepatic chemotherapy or prior systemic chemotherapy
within 4 weeks.
- Concurrent malignancy.
- Pregnant or breast-feeding women.
- History of life-threatening contrast allergy.
Front Range Cancer Specialists, Fort Collins, Colorado 80524, United States
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida 32207, United States
Winship Cancer Institute of Emory University, Altanta, Georgia 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia 30033, United States
Rush-Copley Cancer Care Center, Aurora, Illinois 60507, United States
Hematology and Oncology Associates, Chicago, Illinois 60611, United States
Mercy Hospital and Medical Center, Chicago, Illinois 60616, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States
Swedish Covenant Hospital, Chicago, Illinois 60625, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois 60611, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois 60521, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois 60435, United States
Midwest Center for Hematology/Oncology, Joliet, Illinois 60432, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois 60048, United States
Hematology Oncology Associates - Skokie, Skokie, Illinois 60076, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center, Skokie, Illinois 60076, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois 61801, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana 46360, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa 50316-2301, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa 50314, United States
Mercy Capitol Hospital, Des Moines, Iowa 50307, United States
Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa 50266, United States
Borgess Medical Center, Kalamazooaa, Michigan 49001, United States
Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007-3731, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown, New Jersey 07962, United States
Somerset Medical Center, Somerville, New Jersey 08876, United States
Overlook Hospital, Summit, New Jersey 07902, United States
Case Comprehensive Cancer Center, Cleveland, Ohio 44106, United States
St. Rita's Medical Center, Lima, Ohio 45801, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania 19141, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania 19111-2497, United States