Hepatocellular CarcinomaPhase 2NCT01032850
Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
A Phase 2 study testing Sorafenib & Capecitabine in people with Hepatocellular Carcinoma, run by New Mexico Cancer Research Alliance at 3 sites in United States.
Trial summary
This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following: how effective this combination of study drugs will be in treating HCC how long subjects respond to these study drugs what types of side effects can be expected, and how severe the side effects are All subjects in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib & Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to Aug 2017
- 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
- Histologic diagnosis of hepatocellular carcinoma The lesion or lesions are not resectable with curative intent. Prior loco-regional treatment (resection, RFA, chemoembolization) is allowed.
- Adequate bone marrow function:
- Absolute neutrophil count (AGC) >1500/µL
- Platelet count >60,000 /µL
- Renal function:
- Serum creatinine < 2.0 mg/dl, and a calculated CCT of > 30 mL/min. Hepatic function:(Patients with a Child-Pugh (C-P) class A-B)
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- Bilirubin < 2.8 mg/dl (provided the Child-Pugh class of liver cirrhosis is A or B (7) (ie. The Child-Pugh score is only 7 points)
- ALT and AST ≤ 5.0 times the ULN • Hemoglobin > 8.5 g/dl
- ECOG/Zubrod/SWOG Performance Status = 0>1 Life expectancy > 16 weeks Male or female' age >18 years Patients of childbearing potential must be using an effective means of contraception.
- INR < 1.5 or a PT/PTT within normal limits.
Who cannot join
- Any prior systemic therapy including chemotherapy of targeted agents
- Uncontrolled ascites defined as not easily controlled by stable doses of diuretics.
- Pregnant or lactating females
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Uncontrolled' clinically significant dysrhythmia
- History of prior malignancy within the prior 3 years, with the exception of non-melanoma carcinomas of the skin, carcinoma in situ of the cervix or breast, Rai Stage I chronic lymphocytic leukemia and superficial bladder cancer.
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- Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
- Uncontrolled metastatic disease of the central nervous system
- Radiotherapy within the 2 weeks before Cycle 1' Day 1
- Surgery within the 2 weeks before Cycle 1' Day 1
- Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection.
- Patients with chronic Hepatitis B or C infections are eligible.
- Active clinically serious infection > CTCAE Grade 2.
- 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.
- Evidence or history of bleeding diathesis or coagulopathy.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
- Any malabsorption problem.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Cancer Center at Presbyterian Hospital
Albuquerque, New Mexico, 87110
About this study
Official title: Sorafenib in Combination With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following:
- how effective this combination of study drugs will be in treating HCC
- how long subjects respond to these study drugs
- what types of side effects can be expected, and
- how severe the side effects are
All subjects in this study will receive:
- Sorafenib twice a day by mouth
- Capecitabine twice a day by mouth
Treatment will be given in a 28-day treatment cycle.
Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days 1-7 and 15-21 of the cycle
Read the detailed description
Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world. HCC disproportionately affects men, with four times as many men developing the disease as women. In 2002, approximately 626,000 cases of HCC were reported worldwide (15,000 in the United States and 53,600 in Europe), and more than 600,000 deaths (about 13,000 Americans and 57,000 Europeans) due to HCC were reported. The five-year relative survival rate is about seven percent.
The Gem-Ox regimen has been used in the treatment of pancreatic cancer with encouraging results. Preliminary results of the Gem-Ox combination have been encouraging as well.Based on these observations the possibility of adding bevacizumab, a monoclonal antibody against VEGF, is being studied by other investigators. However, the combination of GEM-OX with bevacizumab is unlikely to be tolerated by HCC patients with Child-Pugh class B and C liver cirrhosis especially those with significant thrombocytopenia.It would seem therefore that the agents that could be tolerated by cirrhotic patients with advanced HCC would include capecitabine, erlotinib and sorafenib. We propose this phase II trial of sorafenib + capecitabine combination in patients with HCC and advanced liver cirrhosis who have a platelet count of ≥ 40,000 and a Child-Pugh (C-P) class A-and B liver cirrhosis with a life expectancy of ≥16 weeks.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib & Capecitabine
- Keywords
- INST 0820, sorafenib, capecitabine, hepatocellular carcinoma, lung, nexavar, xeloda, liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib & CapecitabineDrug
Also called Sorafenib, Capecitabine, Nexavar, Xeloda
Intervention: Sorafenib twice a day by mouth (400mg), Capecitabine twice a day by mouth (850mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Sorafenib & Capecitabine | Experimental | Intervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400mg) Capecitabine twice a day by mouth (850mg) Receives: Drug: Sorafenib & Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.
Measured: 6 months
Secondary outcomes (3)
Disease Control Rate of Response (DCR)
Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease control rate (DCR) is the sum of the percentages of patients achieving complete and partial responses and stable disease
Measured: 6 months
Overall Survival (OS)
The time from treatment initiation to death by any cause
Measured: 5 years
Progression Free Survival (PFS)
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionAug 2017
Why it stopped: Low accrual rate
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 Hepatocellular CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Yehuda Z. Patt, MD, Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032850
- Sponsor's protocol ID
- INST 0820
- Other IDs
- NCI-2011-02945
- Status last verified
- Jun 2016
- First submitted
- 14 Dec 2009
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Patt Y, Rojas-Hernandez C, Fekrazad HM, Bansal P, Lee FC. Phase II Trial of Sorafenib in Combination with Capecitabine in Patients with Hepatocellular Carcinoma: INST 08-20. Oncologist. 2017 Oct;22(10):1158-e116. doi: 10.1634/theoncologist.2017-0168. Epub 2017 Jul 7.
PubMed 28687627
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib in Combination With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01032850
- Acronym / sponsor ID
- INST 0820
- Conditions
- Hepatocellular Carcinoma
- Keywords
- INST 0820, sorafenib, capecitabine, hepatocellular carcinoma, lung, nexavar, xeloda, liver cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 15 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Posted 17 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following:
- how effective this combination of study drugs will be in treating HCC
- how long subjects respond to these study drugs
- what types of side effects can be expected, and
- how severe the side effects are
All subjects in this study will receive:
- Sorafenib twice a day by mouth
- Capecitabine twice a day by mouth
Treatment will be given in a 28-day treatment cycle.
Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days 1-7 and 15-21 of the cycle
Detailed description
Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world. HCC disproportionately affects men, with four times as many men developing the disease as women. In 2002, approximately 626,000 cases of HCC were reported worldwide (15,000 in the United States and 53,600 in Europe), and more than 600,000 deaths (about 13,000 Americans and 57,000 Europeans) due to HCC were reported. The five-year relative survival rate is about seven percent.
The Gem-Ox regimen has been used in the treatment of pancreatic cancer with encouraging results. Preliminary results of the Gem-Ox combination have been encouraging as well.Based on these observations the possibility of adding bevacizumab, a monoclonal antibody against VEGF, is being studied by other investigators. However, the combination of GEM-OX with bevacizumab is unlikely to be tolerated by HCC patients with Child-Pugh class B and C liver cirrhosis especially those with significant thrombocytopenia.It would seem therefore that the agents that could be tolerated by cirrhotic patients with advanced HCC would include capecitabine, erlotinib and sorafenib. We propose this phase II trial of sorafenib + capecitabine combination in patients with HCC and advanced liver cirrhosis who have a platelet count of ≥ 40,000 and a Child-Pugh (C-P) class A-and B liver cirrhosis with a life expectancy of ≥16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Sorafenib & Capecitabine | Experimental | Drug: Sorafenib & CapecitabineIntervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400mg) Capecitabine twice a day by mouth (850mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologic diagnosis of hepatocellular carcinoma The lesion or lesions are not resectable with curative intent. Prior loco-regional treatment (resection, RFA, chemoembolization) is allowed.
- Absolute neutrophil count (AGC) >1500/µL
- Platelet count >60,000 /µL
- Serum creatinine < 2.0 mg/dl, and a calculated CCT of > 30 mL/min. Hepatic function:(Patients with a Child-Pugh (C-P) class A-B)
- Bilirubin < 2.8 mg/dl (provided the Child-Pugh class of liver cirrhosis is A or B (7) (ie. The Child-Pugh score is only 7 points)
Key exclusion criteria (24 listed)
- Any prior systemic therapy including chemotherapy of targeted agents
- Uncontrolled ascites defined as not easily controlled by stable doses of diuretics.
- Pregnant or lactating females
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Uncontrolled' clinically significant dysrhythmia
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 |
|---|---|---|
| Sorafenib & CapecitabineAlso: Sorafenib, Capecitabine, Nexavar, XelodaIntervention: Sorafenib twice a day by mouth (400mg), Capecitabine twice a day by mouth (850mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days. | Drug | Arm 1: Sorafenib & Capecitabine |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: 6 months
The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.
3 secondary outcomes
Disease Control Rate of Response (DCR)
Time frame: 6 months
Overall Survival (OS)
Time frame: 5 years
Progression Free Survival (PFS)
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28687627Patt Y, Rojas-Hernandez C, Fekrazad HM, Bansal P, Lee FC. Phase II Trial of Sorafenib in Combination with Capecitabine in Patients with Hepatocellular Carcinoma: INST 08-20. Oncologist. 2017 Oct;22(10):1158-e116. doi: 10.1634/theoncologist.2017-0168. Epub 2017 Jul 7.
- University of New Mexico Cancer CenterLink provided by the sponsor.
- New Mexico Cancer Care AllianceLink provided by the sponsor.
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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.
Yehuda Z. Patt, MD principal investigator
University of New Mexico Cancer Center
3 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 Sorafenib & Capecitabine in people with Hepatocellular Carcinoma, run by New Mexico Cancer Research Alliance at 3 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 10 inclusion and 24 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 17 Jul 2015). 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?
Number of Participants Experiencing Adverse Events (time frame: 6 months). 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 NCT01032850, 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 2 Jun 2021.