Liver CancerNCT00293397
Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
A study testing Drug-eluting beads loaded with doxorubicin hydrochloride in people with Liver Cancer, run by Yale University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Drug-eluting beads loaded with doxorubicin hydrochloride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Apr 2011
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification
- No advanced disease, as defined by any of the following:
- Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following:
- Vascular invasion, including segmental portal obstruction
- Extrahepatic spread
- Cancer-related symptoms (PST of 1-2)
- BCLC class D disease, as defined by the following:
- Okuda stage III disease
- World Health Organization (WHO) performance status 3 or 4
- Diffuse HCC, defined as massive ill-defined tumor involvement
- Child-Pugh Class C
- Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies)
- No significant liver decompensation
- Preserved liver function (Child-Pugh class A-B)
- No ascites (trace ascites allowed)
- No other active primary tumor
- Arteries supplying the lesion must be large enough to accept GelSpheres™ beads
PATIENT CHARACTERISTICS:
- Bilirubin ≤ 3 mg/dL
- Albumin > 2.0 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
- No active gastrointestinal bleeding
- No encephalopathy
- No contraindication to hepatic embolization procedures, as indicated by any of the following:
- Porto-systemic shunt
- Hepatofugal blood flow
- Platelet count < 50,000/mm^3
- International normalized ratio (INR) ≥ 1.8
- Partial thromboplastin time (PTT) ≥ 39 seconds
- Renal failure
- Severe atheromatosis
- No contraindication to doxorubicin hydrochloride administration, as indicated by any of the following:
- Bilirubin > 5 mg/dL
- White blood cell (WBC) < 1,500/mm^3
- Ejection fraction < 50% by isotopic ventriculography or echocardiography
- Not pregnant
- No known allergy to contrast media
- No intolerance to occlusion procedures
- No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:
- Active or risk of hemorrhage
- Patent extra-to-intracranial anastomoses or shunts
- End arteries leading directly to the cranial nerves
- Feeding arteries smaller than distal branches from which they emerge
- Collateral vessel pathways that would potentially endanger normal territories during embolization
PRIOR CONCURRENT THERAPY:
- No prior anticancer therapy for HCC
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.
PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works in treating patients with liver cancer that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
- Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular carcinoma.
OUTLINE: This is a pilot study.
Patients undergo catheterization of the hepatic artery followed by chemoembolization comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the target hepatic artery. Patients may receive up to 3 chemoembolization treatments.
After completion of study treatment, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months during year 2.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Conditions
- Liver Cancer
- Being tested
- Drug-eluting beads loaded with doxorubicin hydrochloride
- Keywords
- adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting beads loaded with doxorubicin hydrochlorideDevice
Also called Gelspheres, LC Beads
Doxorubicin eluting beads
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting bead transarterial chemoembolization (DEB-TACE) | Experimental | Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. Receives: Device: Drug-eluting beads loaded with doxorubicin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
Measured: 1 month
Safety
Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
Measured: 6 months
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Efficacy as assessed by radiographic tumor response using EASL criteria at baseline and at 1 month post-TACE
Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions.
Measured: 1 month
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 1 month post treatment.
Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Measured: 1 month
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, and at 6 months post treatment.
Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Measured: 6 months
Efficacy - Overall Survival
Presented are the counts of patients that have survived up to 1 year.
Measured: 1 Year
Efficacy - Overall Survival
Presented are the counts of patients that have survived up to 2 years.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionApr 2011
- Study completionApr 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey F. Geschwind, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293397
- Sponsor's protocol ID
- CDR0000456493
- Other IDs
- P30CA006973, JHOC-J0516, HOC-05042805
- Status last verified
- Jun 2018
- First submitted
- 16 Feb 2006
- Last updated
- 18 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Reyes DK, Vossen JA, Kamel IR, Azad NS, Wahlin TA, Torbenson MS, Choti MA, Geschwind JF. Single-center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: initial experience in the United States. Cancer J. 2009 Nov-Dec;15(6):526-32. doi: 10.1097/PPO.0b013e3181c5214b.
PubMed 20010173
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization
- ClinicalTrials.gov ID
- NCT00293397
- Acronym / sponsor ID
- CDR0000456493
- Conditions
- Liver Cancer
- Keywords
- adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Posted 18 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.
PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works in treating patients with liver cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES:
- Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular carcinoma.
OUTLINE: This is a pilot study.
Patients undergo catheterization of the hepatic artery followed by chemoembolization comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the target hepatic artery. Patients may receive up to 3 chemoembolization treatments.
After completion of study treatment, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months during year 2.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting bead transarterial chemoembolization (DEB-TACE) | Experimental | Device: Drug-eluting beads loaded with doxorubicin hydrochloridePatients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Drug-eluting beads loaded with doxorubicin hydrochlorideAlso: Gelspheres, LC BeadsDoxorubicin eluting beads | Device | Drug-eluting bead transarterial chemoembolization (DEB-TACE) |
Primary outcome
Safety
Time frame: 1 month
Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
Safety
Time frame: 6 months
Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
Time frame: 1 month
Efficacy as assessed by radiographic tumor response using EASL criteria at baseline and at 1 month post-TACE Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions.
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 1 month
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 1 month post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 6 months
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, and at 6 months post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Efficacy - Overall Survival
Time frame: 1 Year
Presented are the counts of patients that have survived up to 1 year.
Efficacy - Overall Survival
Time frame: 2 Years
Presented are the counts of patients that have survived up to 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20010173Reyes DK, Vossen JA, Kamel IR, Azad NS, Wahlin TA, Torbenson MS, Choti MA, Geschwind JF. Single-center phase II trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma: initial experience in the United States. Cancer J. 2009 Nov-Dec;15(6):526-32. doi: 10.1097/PPO.0b013e3181c5214b.
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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.
Jeffrey F. Geschwind, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting beads loaded with doxorubicin hydrochloride in people with Liver Cancer, run by Yale University at 1 site 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?
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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2018). 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?
Safety (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00293397, which also lists 1 linked publication.
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 18 Jul 2018.