Hepatocellular CarcinomaPhase 2NCT00287222
Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma
A Phase 2 study testing Bevacizumab and Erlotinib in people with Hepatocellular Carcinoma, run by University of Arkansas at 2 sites in United States.
Trial summary
The primary efficacy endpoint will be the proportion of subjects that remain free of progression at the 27th week following the onset of treatment. Secondary objectives include the subject's time in weeks from treatment onset to documented disease progression as assessed by the RECIST criteria, response rate, median… 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?
- Bevacizumab and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects should have histologically or cytologically confirmed diagnosis of hepatocellular carcinoma, regardless of biopsy site.
- Subjects with a liver mass and markedly elevated AFP (>500ng/mL) are eligible.
- Subjects should not be on the liver transplantation schedule
- Subjects can have prior therapy with sorafenib (nexavar) only if the therapy was stopped due to toxicity or allergic reaction soon after starting. Subjects must have been treated for less than two weeks to be eligible.
- Radiation therapy for palliation to the areas outside the site of tumor used for measurements is permitted. If a subject has received radiation therapy to the liver, the subject id eligible if there is a new lesion or if the prior lesion has increased in size.
- Subjects who have recovered from prior surgical procedure
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- Performance status of ECOG 0-2
- Measurable or evaluable disease
- Be declared unresectable or not suitable candidates for surgery
- Adequate organ functions
- Serum bilirubin <3 mg/dl, AST <5x ULN, ALT <5XULN
- Serum albumin >2.5 g/dl
- Serum creatinine < 2.0 mg/dl
- ANC >1200 MM3
- Platelet count >75,000/ml
- PT/INR < 1.5 X ULN
- Life expectancy of >3 months
- Subjects should be able to sign informed consent and be agreeing to comply with therapy and follow up.
- Negative pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
- Fertile men and women must agree to use adequate contraception prior to study entry, for the duration of study participation, and for at least 1 week after therapy.
- Age >/= 18 years. The agents Bevacizumab and Erlotinib have not been studied in pediatric subjects, thus the doses to be used in this study cannot be assumed to be safe in children.
Who cannot join
- Surgically resectable disease
- Subjects with active bacterial infections
- Subjects with brain metastases
- Pregnant women (positive pregnancy test) or lactating
- No other malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the subject has been disease-free for five years.
- Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sjogren's syndrome) or congenital abnormality (e.g. Fuch's dystrophy).
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- Current, recent (within 4 weeks of the first infusion of the study), or planned participation in an experimental drug study other than a Genentech-sponsored Bevacizumab/Erlotinib cancer study
- Hepatic encephelopathy (as per treating physician's evaluation)
- Uncontrolled blood Pressure >150/100 mmHg
- Unstable angina
- NYHA grade II or greater congestive heart failure
- History or myocardial infraction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease (clinically significant venous or arterial thrombotic disease).
- Evidence of bleeding diathesis or coagulopathy
- Urine protein: creatinine ratio >1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to comply with study and/or follow-up procedures
- Gastrointestinal disease resulting in an inability to take oral medication or a requirement for intravenous hyperalimentation.
- History of significant gastrointestinal bleeding requiring procedural intervention (e.g. variceal banding, TIPS procedure, arterial embolization, topical coagulation therapy) within six months prior to study Day 0.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kansas University Medical Center
Kansas City, Kansas, 66160
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
The primary efficacy endpoint will be the proportion of subjects that remain free of progression at the 27th week following the onset of treatment. Secondary objectives include the subject's time in weeks from treatment onset to documented disease progression as assessed by the RECIST criteria, response rate, median and overall survival, safety and tolerability.
Read the detailed description
This is a phase II study to assess the proportion of subjects that remain progression-free by the 27th week following the onset of treatment and to assess the efficacy of the combination of Bevacizumab and Erlotinib in prolonging time to progression in subjects with inoperable and metastatic hepatocellular carcinoma. Subjects will be treated with a combination of rhuMAb VEGF (Bevacizumab), in combination with Erlotinib and TTP will be assessed as per RECIST criteria. The disease will be evaluated at base line and every 9 weeks with CT scan/MRI and AFP levels. Subjects will be kept on the study till disease progression (as defined by RECIST criteria) or death.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Bevacizumab, Erlotinib
- Keywords
- Inoperable and Metastatic Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
15 mg/KG I.V. every 21 days
ErlotinibDrug
Also called Tarceva
150 mg orally every day
| Study group | Role | What they receive |
|---|---|---|
| 1 - Bevacizumab/Erlotinib | Experimental | Subjects will be treated with bevacizumab and erlotinib Receives: Drug: Bevacizumab; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Remained Free of Progression at the 27th Week.
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2010
- Study completionSep 2010
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.
- More trials run by University of ArkansasThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Rangaswamy Govindarajan, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287222
- Sponsor's protocol ID
- UARK 2005-13
- Status last verified
- Jun 2011
- First submitted
- 3 Feb 2006
- Last updated
- 15 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Govindarajan R, Siegel E, Makhoul I, Williamson S. Bevacizumab and erlotinib in previously untreated inoperable and metastatic hepatocellular carcinoma. Am J Clin Oncol. 2013 Jun;36(3):254-7. doi: 10.1097/COC.0b013e318248d83f.
PubMed 22643560
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00287222
- Acronym / sponsor ID
- UARK 2005-13
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Inoperable and Metastatic Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Posted 15 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary efficacy endpoint will be the proportion of subjects that remain free of progression at the 27th week following the onset of treatment. Secondary objectives include the subject's time in weeks from treatment onset to documented disease progression as assessed by the RECIST criteria, response rate, median and overall survival, safety and tolerability.
Detailed description
This is a phase II study to assess the proportion of subjects that remain progression-free by the 27th week following the onset of treatment and to assess the efficacy of the combination of Bevacizumab and Erlotinib in prolonging time to progression in subjects with inoperable and metastatic hepatocellular carcinoma. Subjects will be treated with a combination of rhuMAb VEGF (Bevacizumab), in combination with Erlotinib and TTP will be assessed as per RECIST criteria. The disease will be evaluated at base line and every 9 weeks with CT scan/MRI and AFP levels. Subjects will be kept on the study till disease progression (as defined by RECIST criteria) or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 - Bevacizumab/Erlotinib | Experimental | Drug: Bevacizumab, Drug: ErlotinibSubjects will be treated with bevacizumab and erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subjects should have histologically or cytologically confirmed diagnosis of hepatocellular carcinoma, regardless of biopsy site.
- Subjects with a liver mass and markedly elevated AFP (>500ng/mL) are eligible.
- Subjects should not be on the liver transplantation schedule
- Subjects can have prior therapy with sorafenib (nexavar) only if the therapy was stopped due to toxicity or allergic reaction soon after starting. Subjects must have been treated for less than two weeks to be eligible.
- Radiation therapy for palliation to the areas outside the site of tumor used for measurements is permitted. If a subject has received radiation therapy to the liver, the subject id eligible if there is a new lesion or if the prior lesion has increased in size.
Key exclusion criteria (23 listed)
- Surgically resectable disease
- Subjects with active bacterial infections
- Subjects with brain metastases
- Pregnant women (positive pregnancy test) or lactating
- No other malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the subject has been disease-free for five years.
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 |
|---|---|---|
| BevacizumabAlso: Avastin15 mg/KG I.V. every 21 days | Drug | 1 - Bevacizumab/Erlotinib |
| ErlotinibAlso: Tarceva150 mg orally every day | Drug | 1 - Bevacizumab/Erlotinib |
Primary outcome
Number of Participants Who Remained Free of Progression at the 27th Week.
Time frame: 27 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22643560Govindarajan R, Siegel E, Makhoul I, Williamson S. Bevacizumab and erlotinib in previously untreated inoperable and metastatic hepatocellular carcinoma. Am J Clin Oncol. 2013 Jun;36(3):254-7. doi: 10.1097/COC.0b013e318248d83f.
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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.
Rangaswamy Govindarajan, MD principal investigator
University of Arkansas
2 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 Bevacizumab and Erlotinib in people with Hepatocellular Carcinoma, run by University of Arkansas at 2 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 21 inclusion and 23 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 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 15 Jul 2011). 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 Who Remained Free of Progression at the 27th Week. (time frame: 27 weeks). 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 NCT00287222, 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 15 Jul 2011.