Carcinoma, HepatocellularPhase 2NCT00576056
Effectiveness and Safety Study of TACE Plus Oral Sorafenib for Unresectable HCC
A Phase 2 study testing Sorafenib and TACE in people with Carcinoma, Hepatocellular, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Sorafenib and TACE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2010
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with HCC seen at UPMC will be enrolled in this study if they meet the following eligibility criteria:
- Adults patients (≥ 18 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
- Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200
- Patient must have quantifiable disease limited to the liver
- Patients must have at least one tumor lesion that meets both of the following criteria:
- The lesion can be accurately measured in at least one dimension according to RECIST criteria
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- The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- ECOG performance status (PS) <2
- No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
- At least 4 weeks since prior TACE
- At least 4 weeks since prior interferon
- Not pregnant
- No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
- No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
- No current infections requiring antibiotic therapy
- Not on anticoagulation or suffering from a known bleeding disorder
- No unstable coronary artery disease or recent MI
- The following laboratory parameters:
- Platelet count ≥ 60,000/µL
- Hemoglobin ≥ 8.5 g/dL
- Total bilirubin ≤ 1.5 mg/dL
- ASL and AST ≤ 5 x upper limit of normal
- Serum creatinine ≤ 1.5 x upper limit of normal
- INR ≤ 1.5 or a Pt/PTT within normal limits
- Absolute neutrophil count (ANC) > 1,500/mm3
- Ability to understand the protocol and to agree to and sign a written informed consent document
Who cannot join
- Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated > 3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis
- Child-Pugh B \& C hepatic impairment
- History of cardiac disease: > NY Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
- Active clinically serious infections (> CTCAEv3 grade 2)
- Known history of HIV
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- Known central nervous system tumors including metastatic brain disease
- History of organ allograft
- Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Patients unable to swallow oral medications.
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Excluded therapies and medications, previous and concomitant:
- Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors, or farnesyl transferase inhibitors
- Major surgery within 6 weeks of start of study drug
- Radiotherapy during study or within 3 weeks prior to start of study drug.
- Use of biologic response modifiers such as granulocyte colony-stimulating factor (G-CSF) within 3 weeks prior to study entry.
- Autologous bone marrow transplant or stem cell rescue within four months of study drug initiation
- Concomitant treatment with rifampin or St. John's wort.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Phase II Trial of Transcatheter Arterial Chemoembolization (TACE) Plus Oral Sorafenib (BAY 43-9006, Nexavar®) for Unresectable Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery.
Read the detailed description
The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC, but this will also be the first clinical trial with sorafenib to assess the effects of this novel therapy on HRQL. Understanding the effects of sorafenib on HRQL is critical in the treatment of HCC secondary to the modest benefits in survival that have been reported with conventional therapies. Our team has one of the largest experiences in evaluating HRQL in patients diagnosed with unresectable hepatocellular carcinoma. We have previously reported on alternative methods of evaluating HRQL, solutions for missing data in clinical trials as well as tested statistical and clinically meaningful differences, within and between treatment groups, in clinical trials with patients diagnosed with hepatobiliary carcinoma.
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular, Carcinoma, TACE, Sorafenib, Transcatheter Arterial Chemoembolization, Nexavar, Unresectable
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.
TACEDrug
Also called Transarterial Chemoembolization
TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin.
| Study group | Role | What they receive |
|---|---|---|
| Tace and Sorafenib | Experimental | Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment. Receives: Drug: Sorafenib; Drug: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality
Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 24 months (from initial treatment through 12 months follow-up)
Secondary outcomes (1)
Determine the Overall Survival in Patients Treated With This Combination Regimen
Overall survival (OS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of death. For a surviving patient, OS is censored by the last follow-up date when that patient is documented to be alive.
Measured: From date of initial treatment until the date of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionApr 2010
Why it stopped: Bayer Healthcare is no supplying the study drug
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 Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Susan Lamson, RN, BA, University of Pittsburgh
- Investigators
- Thomas C Gamblin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576056
- Sponsor's protocol ID
- 07-047
- Status last verified
- Nov 2016
- First submitted
- 14 Dec 2007
- Last updated
- 15 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Transcatheter Arterial Chemoembolization (TACE) Plus Oral Sorafenib (BAY 43-9006, Nexavar®) for Unresectable Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00576056
- Acronym / sponsor ID
- 07-047
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular, Carcinoma, TACE, Sorafenib, Transcatheter Arterial Chemoembolization, Nexavar, Unresectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Bayer Healthcare is no supplying the study drug
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jan 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Posted 28 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery.
Detailed description
The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC, but this will also be the first clinical trial with sorafenib to assess the effects of this novel therapy on HRQL. Understanding the effects of sorafenib on HRQL is critical in the treatment of HCC secondary to the modest benefits in survival that have been reported with conventional therapies. Our team has one of the largest experiences in evaluating HRQL in patients diagnosed with unresectable hepatocellular carcinoma. We have previously reported on alternative methods of evaluating HRQL, solutions for missing data in clinical trials as well as tested statistical and clinically meaningful differences, within and between treatment groups, in clinical trials with patients diagnosed with hepatobiliary carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tace and Sorafenib | Experimental | Drug: Sorafenib, Drug: TACEPatients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Adult patients with HCC seen at UPMC will be enrolled in this study if they meet the following eligibility criteria:
- Adults patients (≥ 18 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
- Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200
- Patient must have quantifiable disease limited to the liver
- Patients must have at least one tumor lesion that meets both of the following criteria:
Key exclusion criteria (25 listed)
- Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated > 3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis
- Child-Pugh B \& C hepatic impairment
- History of cardiac disease: > NY Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
- Active clinically serious infections (> CTCAEv3 grade 2)
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 |
|---|---|---|
| SorafenibAlso: NexavarOral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination. | Drug | Tace and Sorafenib |
| TACEAlso: Transarterial ChemoembolizationTACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. | Drug | Tace and Sorafenib |
Primary outcome
Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality
Time frame: Up to 24 months (from initial treatment through 12 months follow-up)
Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
1 secondary outcome
Determine the Overall Survival in Patients Treated With This Combination Regimen
Time frame: From date of initial treatment until the date of death from any cause
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Thomas C Gamblin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib and TACE in people with Carcinoma, Hepatocellular, run by University of Pittsburgh 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?
The sponsor lists 26 inclusion and 25 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: stopped early, as of the sponsor's last update on 15 Feb 2017. 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.
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 28 Dec 2016). 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?
Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality (time frame: Up to 24 months (from initial treatment through 12 months follow-up)). 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 15 Feb 2017.