Liver CancerPhase 2NCT00003907
Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
A Phase 2 study testing cisplatin, doxorubicin and mitomycin in people with Liver Cancer and Metastatic Cancer, run by Eastern Cooperative Oncology Group at 37 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Metastatic Cancer
- What is being tested?
- cisplatin, doxorubicin and mitomycin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 37 sitesUnited States
- Study dates
- 15 Dec 1999to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Expected survival of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age >= 18 years.
Who cannot join
- 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.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Hematology and Oncology Associates
Chicago, Illinois, 60611
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
Mercy Hospital and Medical Center
Chicago, Illinois, 60616
Swedish Covenant Hospital
Chicago, Illinois, 60625
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
Mercy Capitol Hospital
Des Moines, Iowa, 50307
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
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
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
Front Range Cancer Specialists
Fort Collins, Colorado, 80524
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435
Borgess Medical Center
Kalamazoo, Michigan, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, 60048
St. Rita's Medical Center
Lima, Ohio, 45801
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, 60076
Somerset Medical Center
Somerville, New Jersey, 08876
Overlook Hospital
Summit, New Jersey, 07902
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, 50266
About this study
Official title: Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial
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.
Read the 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.
- Conditions
- Liver Cancer, Metastatic Cancer
- Being tested
- cisplatin, doxorubicin, mitomycin, embolization
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma, liver metastases
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Also called Cis-diaminedichloroplatinum Cis-diaminedichloroplatinum (II),, diaminedichloroplatinum,, cis-platinum,, platinum,
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).
doxorubicinDrug
Also called Adriamycin,, Rubex,, Adriamycin RDF,, Adriamycin PFS,
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).
mitomycinDrug
Also called Mutamycin,
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).
embolizationProcedure or surgery
Also called trans-arterial chemoembolization,, TACE
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.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma | Experimental | 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. Receives: Drug: cisplatin; Drug: doxorubicin; Drug: mitomycin; Procedure: embolization |
| Neuroendocrine hepatic metastases | Experimental | 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. Receives: Drug: cisplatin; Drug: doxorubicin; Drug: mitomycin; Procedure: embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed every 3 months for 2 years, then every 6 months for 3 year.
Secondary outcomes (2)
Tumor Response
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.
Measured: Assessed every 6 weeks
Overall Survival
Overall survival was defined as time from registration to death from any causes.
Measured: Assessed every 3 months for 2 years, then every 6 months for 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2003 (estimated)
- Study start15 Dec 1999
- Primary completionMay 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Keith E. Stuart, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003907
- Sponsor's protocol ID
- CDR0000067083
- Other IDs
- U10CA021115, E4298
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 5 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoembolization in Hepatocellular Carcinoma or Neuroendocrine Hepatic Metastases: A Phase II Multi-Center Trial
- ClinicalTrials.gov ID
- NCT00003907
- Acronym / sponsor ID
- CDR0000067083
- Conditions
- Liver Cancer, Metastatic Cancer
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma, liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Dec 1999 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Oct 2003 (estimated)
- Results
- Posted 8 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma | Experimental | Drug: cisplatin, Drug: doxorubicin, Drug: mitomycin, Procedure: embolizationChemoemulsion (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 | Experimental | Drug: cisplatin, Drug: doxorubicin, Drug: mitomycin, Procedure: embolizationChemoemulsion (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatinAlso: Cis-diaminedichloroplatinum Cis-diaminedichloroplatinum (II),, diaminedichloroplatinum,, cis-platinum,, platinum,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). | Drug | Hepatocellular carcinoma, Neuroendocrine hepatic metastases |
| doxorubicinAlso: Adriamycin,, Rubex,, Adriamycin RDF,, Adriamycin PFS,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). | Drug | Hepatocellular carcinoma, Neuroendocrine hepatic metastases |
| mitomycinAlso: Mutamycin,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). | Drug | Hepatocellular carcinoma, Neuroendocrine hepatic metastases |
| embolizationAlso: trans-arterial chemoembolization,, TACEImmediately 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. | Procedure or surgery | Hepatocellular carcinoma, Neuroendocrine hepatic metastases |
Primary outcome
Time to Progression
Time frame: 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
2 secondary outcomes
Tumor Response
Time frame: Assessed every 6 weeks
Overall Survival
Time frame: Assessed every 3 months for 2 years, then every 6 months for 3 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith E. Stuart, MD study chair
Beth Israel Deaconess Medical Center
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, doxorubicin and mitomycin in people with Liver Cancer and Metastatic Cancer, run by Eastern Cooperative Oncology Group at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Progression (time frame: Assessed every 3 months for 2 years, then every 6 months for 3 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.