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Liver CancerPhase 2NCT00049322

Chemoembolization and Bevacizumab in Treating Patients With Liver Cancer That Cannot Be Removed With Surgery

A Phase 2 study testing bevacizumab in people with Liver Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, cisplatin, and mitomycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping the cells from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer
What is being tested?
bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Jun 2003to Feb 2012
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

  • Age > 18 year old
  • Histologically or cytologically documented HCC
  • Patients must have bi-dimensional measurable disease by CT or MRI scan that does not exceed 50% of the liver parenchyma
  • Patients must be considered clinical candidates for chemoembolization, with at least one lesion > 3cm and no lesion > 15cm in its longest diameter
  • Patients awaiting cadaveric orthotopic liver transplantation are eligible if they meet all other criteria. These patients must have a model for end-stage liver disease priority score < 28 points at entry
  • Cirrhosis Child-Pugh class A or B
Show all 10Show fewer
  • Patients with documented grad III varices or prior history of UGI bleeding will require endoscopic evaluation prior to treatment under this protocol.
  • Platelet count equal or greater than 60,000/μL
  • Female patients must use effective contraception, be surgically sterile or be postmenopausal; male patients must be using barrier contraception or be surgically sterile
  • Patients must be willing and able to comply with all study requirements and have signed the informed consent

Who cannot join

  • Previous history of liver transplantation
  • Fibrolamellar histology
  • Prior antiangiogenesis therapy
  • Presence of extrahepatic disease
  • Presence of biliary obstruction defined as biliary dilatation and total bilirubin > 2.5mg/dl
  • Thrombosis of the main portal vein
Show all 31Show fewer
  • Absolute contraindications to doxorubicin, mitomycin-C, cisplatin, iodinated contrast material, Avitene or dexamethasone treatment
  • Other active malignancies during the past year (except for non-melanoma skin cancer or in situ carcinomas)
  • ECOG PS> 2 or life expectancy < 12 weeks
  • History or evidence upon physical examination of CNS disease
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure within 3 months of study entry; fine needle aspirations within 7 days prior to Day 0
  • Current or recent (within the 10 days prior to Day 0) use of full-dose oral or parenteral anticoagulants (except as required to maintain patency of preexisting, permanent indwelling IV catheters) or thrombolytic agent (for subjects receiving warfarin, international normalized ration of < 1.5)
  • Chronic, daily treatment with aspirin (> 325mg/day) or nonsteroidal anti-inflammatory medications
  • Positive pregnancy test or lactation
  • Proteinuria at baseline or clinically significant impairment of renal function. Subjects unexpectedly discovered to have > 1+ proteinuria at baseline should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 500 mg of protein/24 hr to allow participation in the study
  • Serious, nonhealing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • Current or recent (within the 28 days prior to Day 0) participation in another experimental drug study
  • Clinically significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year prior to Day 0
  • Prior history of hypertensive crisis of hypertensive encephalopathy
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
  • History of hemoptysis within 1 month prior to Day 1
  • Significant vascular disease within 6 months prior to Day 1
  • Screening clinical laboratory values:
  • ANC of < 1500/μL
  • INR of > 1.5
  • Total bilirubin of > 2.5mg/dL
  • AST or ALT > 5 times upper limit of normal
  • Serum creatinine of > 2.0 mg/dL or creatinine clearance < 45 mL/min
  • Hemoglobin of < 8.5 gm/dL
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: A Phase II Study Of rhuMAb VEGF (BEVACIZUMAB) In Patients With Hepatocellular Carcinoma Receiving Chemoembolization

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, cisplatin, and mitomycin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Monoclonal antibodies, such as bevacizumab, can kill any tumor cells that are left after chemoembolization by blocking their ability to grow and spread.

PURPOSE: This randomized phase II trial is studying to see if chemoembolization followed by bevacizumab works better than chemoembolization alone in treating patients who have liver cancer that cannot be removed with surgery.

Read the detailed description

OBJECTIVES:

  • Compare neovessel formation at 8 and 14 weeks after hepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma treated with bevacizumab versus no bevacizumab (observation after chemoembolization only).
  • Compare time to progression, objective response rate, and tumor marker progression in patients treated with these regimens.
  • Determine the pharmacokinetics of bevacizumab in patients with liver function impairment.
  • Determine the toxic effects of this drug in these patients.
  • Compare the cancer biomarker pattern of peripheral blood cells and plasma before and after chemoembolization in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study.

All patients receive hepatic artery chemotherapy (chemoembolization) comprising doxorubicin HCl liposome, cisplatin, and mitomycin on day 8 and possibly on day 92. Patients are then randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients do not receive bevacizumab. Patients in arm II may cross-over receive bevacizumab as in arm I if recurrent tumor is evident at week 14 by CT scan or MRI or a 50% or greater increase in AFP level has occurred since day 8 chemoembolization.

PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this study.

Conditions
Liver Cancer
Being tested
bevacizumab
Keywords
localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

    Also called Avastin

    Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.

    Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose.

Study groups in NCT00049322
Study groupRoleWhat they receive
Arm I-bevacizumabExperimentalPatients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: bevacizumab
Arm II-chemoembolizationNo interventionchemoembolization as part of standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neovessel Formation as Measured by Angiogram at 14 Weeks

    Angiograms were assessed for changes in vascularity. The numbers indicate how many subjects in each group showed neovessel formation.

    Measured: 14 weeks

Secondary outcomes (4)

  1. Progression Free Survival

    Progression free survival (PFS) at 16 weeks (end of the core phase).

    Measured: 16 weeks

  2. Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment

    Measured: 16 weeks

  3. Assess Pharmakokinetics of Bevacizumab in Liver Disease

    bevacizumab serum concentrations

    Measured: day 85

  4. Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab

    Measured: 21 days after TACE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049322
Sponsor's protocol ID
CDR0000258045
Other IDs
UCLA-0206060, NCI-G02-2124
Status last verified
Feb 2016
First submitted
12 Nov 2002
Last updated
1 Sep 2020
Data monitoring committee
Yes

Publications

  • Britten CD, Gomes AS, Wainberg ZA, Elashoff D, Amado R, Xin Y, Busuttil RW, Slamon DJ, Finn RS. Transarterial chemoembolization plus or minus intravenous bevacizumab in the treatment of hepatocellular cancer: a pilot study. BMC Cancer. 2012 Jan 14;12:16. doi: 10.1186/1471-2407-12-16.

    PubMed 22244160

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab in people with Liver Cancer, run by Jonsson Comprehensive Cancer Center 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 10 inclusion and 31 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 1 Sep 2020. 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 15 Mar 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?

Neovessel Formation as Measured by Angiogram at 14 Weeks (time frame: 14 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 NCT00049322, 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 1 Sep 2020.

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