Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
- Conditions
- Liver CancerMetastatic Cancer
- Interventions
- Registration Number
- NCT00003907
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hepatocellular carcinoma cisplatin Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. Neuroendocrine hepatic metastases embolization Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. Hepatocellular carcinoma embolization Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. Hepatocellular carcinoma doxorubicin Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. Neuroendocrine hepatic metastases doxorubicin Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. Hepatocellular carcinoma mitomycin Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. Neuroendocrine hepatic metastases cisplatin Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. Neuroendocrine hepatic metastases mitomycin Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
- Primary Outcome Measures
Name Time Method Time to Progression Assessed every 3 months for 2 years, then every 6 months for 3 year. 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
- Secondary Outcome Measures
Name Time Method Tumor Response Assessed every 6 weeks Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as \>= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.
Overall Survival Assessed every 3 months for 2 years, then every 6 months for 3 year. Overall survival was defined as time from registration to death from any causes.
Trial Locations
- Locations (37)
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
Mercy Hospital and Medical Center
🇺🇸Chicago, Illinois, United States
Swedish Covenant Hospital
🇺🇸Chicago, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
🇺🇸Skokie, Illinois, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Somerset Medical Center
🇺🇸Somerville, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Baptist Cancer Institute - Jacksonville
🇺🇸Jacksonville, Florida, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Hematology and Oncology Associates
🇺🇸Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Midwest Center for Hematology/Oncology
🇺🇸Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
🇺🇸Libertyville, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Hematology Oncology Associates - Skokie
🇺🇸Skokie, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States