Hepatocellular CarcinomaPhase 2NCT00142467
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma
A Phase 2 study testing Gemcitabine, Oxaliplatin and Bevacizumab in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma. 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?
- Gemcitabine, Oxaliplatin and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2004to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable or metastatic hepatocellular carcinoma
- Measurable tumors
- Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7x ULN
- Adequate bone marrow function: ANC > 1,000/mm3; platelets > 75,000/mm3
- INR < 1.5 for those who are not on anticoagulation
- Up to two prior chemotherapy regimens for hepatocellular carcinoma
Show all 9Show fewer
- 18 years of age or older
- ECOG performance status of 0-1
- Life expectancy of > 12 weeks
Who cannot join
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Uncontrolled serious medical or psychiatric illness
- Pregnant or lactating women
- Current or recent (within 4 weeks of first study infusion) participation in experimental study drug
- Uncontrolled hypertension
- Significant proteinuria
- Serious, non-healing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma
The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.
Read the detailed description
- Treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. Cycle 1 is only 2 weeks long.
- During cycle one only, bevacizumab will be given intravenously on day one. Two weeks after receiving bevacizumab, the patient will return to the clinic for treatment with all 3 study drugs.
- During cycle 2 and every cycle thereafter patients will receive; bevacizumab intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16; oxaliplatin intravenously on day 2 and day 16.
- The following evaluations will be conducted on day 1 and day 15 of each cycle (once every 2 weeks): physical examination, vital signs, medical history, blood tests and urine tests.
- Tumor measurements done by CT and/or MRI will be repeated at the end of cycle 3 and every 2 cycles thereafter.
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) of the liver and Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment during cycle 1, and the Perfusion CT will be repeated at the end of cycle 3.
- Once study treatment is stopped the following evaluations will be performed: physical exam, vital signs, blood work, urine tests, CT scan of chest, abdomen and pelvis, and tumor measurements by CT or MRI scans.
- Follow-up will consist of physical examinations and blood tests every 6 months.
- Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Gemcitabine, Oxaliplatin, Bevacizumab
- Keywords
- Unresectable hepatocellular carcinoma, Metastatic hepatocellular carcinoma, gemcitabine, oxaliplatin, bevacizumab, Avastin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
OxaliplatinDrug
Also called Eloxatin
BevacizumabDrug
Also called Avastin
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab, Gemcitabine, Oxaliplatin | Experimental | For cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death. Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Measured: 2 years
Secondary outcomes (3)
Number of participants with adverse events
Measured: 2 years
Objective response rate
Measured: 2 years
Overall survival
From date of randomization until the date of death from any cause, assessed 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 posted2 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionAug 2006
- Study completionJun 2011
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.
- More trials run by Massachusetts General HospitalThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Sanofi-Synthelabo, Eli Lilly and Company
- Responsible party
- Principal investigator, Andrew X. Zhu, MD, Massachusetts General Hospital
- Investigators
- Andrew Zhu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142467
- Sponsor's protocol ID
- 03-390
- Status last verified
- Mar 2014
- First submitted
- 31 Aug 2005
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00142467
- Acronym / sponsor ID
- 03-390
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Unresectable hepatocellular carcinoma, Metastatic hepatocellular carcinoma, gemcitabine, oxaliplatin, bevacizumab, Avastin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Sanofi-Synthelabo, Eli Lilly and Company
- Study start
- Apr 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Sep 2005 (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.
The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.
Detailed description
- Treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. Cycle 1 is only 2 weeks long.
- During cycle one only, bevacizumab will be given intravenously on day one. Two weeks after receiving bevacizumab, the patient will return to the clinic for treatment with all 3 study drugs.
- During cycle 2 and every cycle thereafter patients will receive; bevacizumab intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16; oxaliplatin intravenously on day 2 and day 16.
- The following evaluations will be conducted on day 1 and day 15 of each cycle (once every 2 weeks): physical examination, vital signs, medical history, blood tests and urine tests.
- Tumor measurements done by CT and/or MRI will be repeated at the end of cycle 3 and every 2 cycles thereafter.
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) of the liver and Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment during cycle 1, and the Perfusion CT will be repeated at the end of cycle 3.
- Once study treatment is stopped the following evaluations will be performed: physical exam, vital signs, blood work, urine tests, CT scan of chest, abdomen and pelvis, and tumor measurements by CT or MRI scans.
- Follow-up will consist of physical examinations and blood tests every 6 months.
- Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab, Gemcitabine, Oxaliplatin | Experimental | Drug: Gemcitabine, Drug: Oxaliplatin, Drug: BevacizumabFor cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Unresectable or metastatic hepatocellular carcinoma
- Measurable tumors
- Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7x ULN
- Adequate bone marrow function: ANC > 1,000/mm3; platelets > 75,000/mm3
- INR < 1.5 for those who are not on anticoagulation
Key exclusion criteria (8 listed)
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Uncontrolled serious medical or psychiatric illness
- Pregnant or lactating women
- Current or recent (within 4 weeks of first study infusion) participation in experimental study drug
- Uncontrolled hypertension
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 |
|---|---|---|
| GemcitabineAlso: Gemzar | Drug | Bevacizumab, Gemcitabine, Oxaliplatin |
| OxaliplatinAlso: Eloxatin | Drug | Bevacizumab, Gemcitabine, Oxaliplatin |
| BevacizumabAlso: Avastin | Drug | Bevacizumab, Gemcitabine, Oxaliplatin |
Primary outcome
Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.
Time frame: 2 years
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
3 secondary outcomes
Number of participants with adverse events
Time frame: 2 years
Objective response rate
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
Andrew Zhu, MD principal investigator
Massachusetts General Hospital
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 Gemcitabine, Oxaliplatin and Bevacizumab in people with Hepatocellular Carcinoma, run by Massachusetts General Hospital 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 9 inclusion and 8 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 18 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma. (time frame: 2 years). 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 18 Mar 2014.