Hepatocellular CarcinomaPhase 2NCT00808145
Study of Sorafenib, Gemcitabine, and Cisplatin in Advanced Hepatocellular Carcinoma (HCC)
A Phase 2 study testing Gemcitabine / Cisplatin / Sorafenib in people with Hepatocellular Carcinoma, run by Lahey Clinic at 1 site in United States.
Trial summary
This study will look at the safety and efficacy of treating advanced hepatocellular carcinoma in patients who have not yet received systemic chemotherapy. Previous local treatment of hepatic lesions is permitted The treatment will use a combination of three FDA approved chemotherapy drugs, Gemcitabine, Cisplatin and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Gemcitabine / Cisplatin / Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma: diagnosed histologically, cytologically, or clinically by a rising AFP > 500 ng/ml in the setting of cirrhosis and a radiographically compatible lesion.
- No prior systemic therapy; local therapy such as chemoembolization, radiofrequency ablation or cryoablation is allowed.
- Measurable disease > 1 cm by CT or MRI. Lesions which have received local therapy do not qualify as measurable target lesions.
- Age > 18 years old
- ECOG Performance Status 0 or 1
- Child-Pugh status A and B
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- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin ≥ 9.0 g/dl
- Absolute neutrophil count (ANC) ≥ 1,250/mm3
- Platelet count ≥ 80,000/mm3
- Total bilirubin ≤ 3.0 mg/dl
- ALT and AST ≤ 5 times the ULN
- Amylase and lipase ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Resolution of all acute toxic effects of any prior local treatment to CTC Adverse Events grade £1.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR or PT and PTT should be measured prior to initiation of sorafenib and monitored at Day 1 and Day 8 of each cycle.
Who cannot join
- Prior surgery, radiation or local therapy within 4 weeks.
- Prior treatment with either sorafenib, gemcitabine, or cisplatin
- 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.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as sustained systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
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- Known human immunodeficiency virus (HIV) infection
- Active clinically serious infection > CTCAE Grade 2.
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib, cisplatin, or gemcitabine.
- Any condition that impairs patient's ability to swallow whole pills.
- Any malabsorption problem.
- Uncontrolled ascites (defined as not easily controlled with diuretic treatment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Sorafenib With Gemcitabine/Cisplatin in Advanced Hepatocellular Carcinoma
This study will look at the safety and efficacy of treating advanced hepatocellular carcinoma in patients who have not yet received systemic chemotherapy. Previous local treatment of hepatic lesions is permitted The treatment will use a combination of three FDA approved chemotherapy drugs, Gemcitabine, Cisplatin and Sorafenib. Sorafenib is FDA approved for the treatment of hepatocellular cancer, gemcitabine and cisplatin are not approved for the treatment of hepatocellular cancer.
Read the detailed description
This study will look at the effectiveness and safety of combining gemcitabine, cisplatin and sorafenib for the treatment of advanced hepatocellular carcinoma in patients with advanced disease who are chemo naive. Sorafenib has shown an increase in median survival but only tumor shrinkage by RECIST criteria. Since much of the morbidity and mortality of this disease occurs due to continued tumor growth in an already compromised liver, decreasing the size of the tumors might have significant impact on survival. The addition of traditional cytoxic agents might cause measureable tumor response and add to the survival benefit already seen with sorafenib. Gemcitabine and cisplatin are agents commonly used for systemic treatment of this disease and have demonstrated some effectiveness in disease control rate and median time to progression. Gemcitabine/Cisplatin have been used safely in combination with sorafenib in patients with lung cancer.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Gemcitabine / Cisplatin / Sorafenib
- Keywords
- Treatment of advanced liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine / Cisplatin / SorafenibDrug
Also called nexavar - sorafenib, gemzar - gemcitabine, cisplatin
All patients will receive gemcitabine 1000mg/m2 cisplatin 30mg/m2 sorafenib 400mg orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/Cisiplatin/Sorafenib | Experimental | All eligible patients will receive intravenous gemcitabine/cisplatin + daily oral sorafenib until disease progression occurs Receives: Drug: Gemcitabine / Cisplatin / Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the combination of gemcitabine/cisplatin/sorafenib
Measured: one year
Secondary outcomes (1)
Effectiveness of gemcitabine/cisplatin/sorafenib in shrinking tumors extending time to progression of disease
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Lack of enrollment, many screen failures and non eligible study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith E. Stuart, M.D., Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808145
- Sponsor's protocol ID
- 2008-108
- Status last verified
- Oct 2014
- First submitted
- 11 Dec 2008
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sorafenib With Gemcitabine/Cisplatin in Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00808145
- Acronym / sponsor ID
- 2008-108
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Treatment of advanced liver cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment, many screen failures and non eligible study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the safety and efficacy of treating advanced hepatocellular carcinoma in patients who have not yet received systemic chemotherapy. Previous local treatment of hepatic lesions is permitted The treatment will use a combination of three FDA approved chemotherapy drugs, Gemcitabine, Cisplatin and Sorafenib. Sorafenib is FDA approved for the treatment of hepatocellular cancer, gemcitabine and cisplatin are not approved for the treatment of hepatocellular cancer.
Detailed description
This study will look at the effectiveness and safety of combining gemcitabine, cisplatin and sorafenib for the treatment of advanced hepatocellular carcinoma in patients with advanced disease who are chemo naive. Sorafenib has shown an increase in median survival but only tumor shrinkage by RECIST criteria. Since much of the morbidity and mortality of this disease occurs due to continued tumor growth in an already compromised liver, decreasing the size of the tumors might have significant impact on survival. The addition of traditional cytoxic agents might cause measureable tumor response and add to the survival benefit already seen with sorafenib. Gemcitabine and cisplatin are agents commonly used for systemic treatment of this disease and have demonstrated some effectiveness in disease control rate and median time to progression. Gemcitabine/Cisplatin have been used safely in combination with sorafenib in patients with lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/Cisiplatin/Sorafenib | Experimental | Drug: Gemcitabine / Cisplatin / SorafenibAll eligible patients will receive intravenous gemcitabine/cisplatin + daily oral sorafenib until disease progression occurs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Hepatocellular carcinoma: diagnosed histologically, cytologically, or clinically by a rising AFP > 500 ng/ml in the setting of cirrhosis and a radiographically compatible lesion.
- No prior systemic therapy; local therapy such as chemoembolization, radiofrequency ablation or cryoablation is allowed.
- Measurable disease > 1 cm by CT or MRI. Lesions which have received local therapy do not qualify as measurable target lesions.
- Age > 18 years old
- ECOG Performance Status 0 or 1
Key exclusion criteria (17 listed)
- Prior surgery, radiation or local therapy within 4 weeks.
- Prior treatment with either sorafenib, gemcitabine, or cisplatin
- 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.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
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 |
|---|---|---|
| Gemcitabine / Cisplatin / SorafenibAlso: nexavar - sorafenib, gemzar - gemcitabine, cisplatinAll patients will receive gemcitabine 1000mg/m2 cisplatin 30mg/m2 sorafenib 400mg orally twice daily | Drug | Gemcitabine/Cisiplatin/Sorafenib |
Primary outcome
Safety of the combination of gemcitabine/cisplatin/sorafenib
Time frame: one year
1 secondary outcome
Effectiveness of gemcitabine/cisplatin/sorafenib in shrinking tumors extending time to progression of disease
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
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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.
Keith E. Stuart, M.D. principal investigator
Lahey Clinic
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 Gemcitabine / Cisplatin / Sorafenib in people with Hepatocellular Carcinoma, run by Lahey Clinic 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 19 inclusion and 17 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: withdrawn, as of the sponsor's last update on 22 Oct 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 of the combination of gemcitabine/cisplatin/sorafenib (time frame: one 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 22 Oct 2014.