Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
NCT ID: NCT00003907
Last Updated: 2023-07-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
1999-12-15
2012-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hepatocellular carcinoma
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.
cisplatin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
doxorubicin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
mitomycin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
embolization
Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.
Neuroendocrine hepatic metastases
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.
cisplatin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
doxorubicin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
mitomycin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
embolization
Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.
Interventions
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cisplatin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
doxorubicin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
mitomycin
Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).
embolization
Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Keith E. Stuart, MD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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Front Range Cancer Specialists
Fort Collins, Colorado, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Hematology and Oncology Associates
Chicago, Illinois, 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
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Mercy Capitol Hospital
Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
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
Medical Oncology and Hematology Associates at Mercy 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
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States
Somerset Medical Center
Somerville, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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E4298
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067083
Identifier Type: -
Identifier Source: org_study_id
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