Chemoembolization and Bevacizumab in Treating Patients With Liver Cancer That Cannot Be Removed With Surgery
A Phase II Study Of rhuMAb VEGF (BEVACIZUMAB) In Patients With Hepatocellular Carcinoma Receiving Chemoembolization
3 other identifiers
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedStudy Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
March 15, 2016
CompletedSeptember 1, 2020
February 1, 2016
8.7 years
November 12, 2002
January 20, 2016
August 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
14 weeks
Secondary Outcomes (4)
Progression Free Survival
16 weeks
Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment
16 weeks
Assess Pharmakokinetics of Bevacizumab in Liver Disease
day 85
Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab
21 days after TACE
Study Arms (2)
Arm I-bevacizumab
EXPERIMENTALPatients 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.
Arm II-chemoembolization
NO INTERVENTIONchemoembolization as part of standard of care
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- Genentech, Inc.collaborator
Study Sites (1)
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781, United States
Related Publications (1)
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.
PMID: 22244160DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Size of study limits any strong conclusions regarding efficacy.Since this study was first designed and implemented, there have been many advances in the field, including confirmation of proof of principal for anti-angiogenic agents in advanced HCC.
Results Point of Contact
- Title
- Carolyn Britten, M.D.
- Organization
- University of California Los Angeles
Study Officials
- PRINCIPAL INVESTIGATOR
Carolyn Britten, MD
Jonsson Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2002
First Posted
January 27, 2003
Study Start
June 1, 2003
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
September 1, 2020
Results First Posted
March 15, 2016
Record last verified: 2016-02