Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial
3 other identifiers
interventional
50
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 1999
Longer than P75 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 1999
CompletedStudy Start
First participant enrolled
December 15, 1999
CompletedFirst Posted
Study publicly available on registry
October 9, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
February 8, 2013
CompletedJuly 5, 2023
June 1, 2023
11.4 years
November 1, 1999
January 7, 2013
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (2)
Tumor Response
Assessed every 6 weeks
Overall Survival
Assessed every 3 months for 2 years, then every 6 months for 3 year.
Study Arms (2)
Hepatocellular carcinoma
EXPERIMENTALChemoemulsion (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
EXPERIMENTALChemoemulsion (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.
Interventions
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 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 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).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
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
Atlanta, 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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611, United States
Mercy Hospital and Medical Center
Chicago, Illinois, 60616, United States
Swedish Covenant Hospital
Chicago, Illinois, 60625, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, 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
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, 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
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, 50266, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, 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
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Keith E. Stuart, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
October 9, 2003
Study Start
December 15, 1999
Primary Completion
May 1, 2011
Study Completion
August 1, 2012
Last Updated
July 5, 2023
Results First Posted
February 8, 2013
Record last verified: 2023-06