NCT00055692

Brief Summary

This phase II trial is to see if bevacizumab works in treating patients who have unresectable nonmetastatic liver cancer that has not spread to the main portal vein. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

February 29, 2016

Completed
Last Updated

February 29, 2016

Status Verified

December 1, 2012

Enrollment Period

4.9 years

First QC Date

March 6, 2003

Results QC Date

August 25, 2015

Last Update Submit

January 29, 2016

Conditions

Adult Primary Hepatocellular CarcinomaLocalized Unresectable Adult Primary Liver CancerRecurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (5)

  • Progression-free Survival

    At 6 months

  • Disease Response

    MRI scan is required at weeks 8, 16 and then every 12 weeks until disease progression. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    MRI is required at weeks 8, 16 and then every 12 weeks until disease progression

  • Mean Arterial Enhancement, Per Lesion, as Determined by Dynamic Gadolinium-enhanced Magnetic Resonance Imaging (MRI), Before and Following Bevacizumab Therapy.

    Baseline and 8 weeks after bevacizumab therapy

  • Assessment on Circulating Levels of VEGF Which Also Contribute to HCC Pathogenesis and on Potential Alterations of These Levels in the Setting of VEGF-inhibition

    During treatment

  • To Collect Information on Hepatic Function and Hepatitis Viral Activity in Cirrhosis and Upon Potential Alterations in the Setting of VEGF-inhibition

    During and after treatment

Other Outcomes (1)

  • Disease Stability

    At 6 months

Study Arms (1)

Treatment (bevacizumab)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.

Biological: bevacizumab

Interventions

bevacizumabBIOLOGICAL

Given orally

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Treatment (bevacizumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed hepatocellular carcinoma
  • Confirmed by needle aspirate, biopsy, or prior surgical resection specimen
  • Clinically confirmed hepatocellular carcinoma defined as follows:
  • Cirrhosis or chronic hepatitis B or C virus infection, with 1 or more hypervascular liver masses more than 2 cm
  • Alpha-fetoprotein (AFP) greater than 400 ng/mL OR greater than 3 times normal and doubling in value during the past 3 months
  • Deemed unresectable
  • Prior surgical resection allowed
  • Recurrence after hepatic resection or other procedure allowed
  • Tumor that extends into branches of the portal or hepatic veins allowed
  • No tumor invading the main portal vein (portal trunk) or inferior vena cava
  • No tumor occupying more than 50% of the liver volume
  • Enlargement/involvement of regional lymph nodes allowed
  • At least 1 unidimensionally measurable lesion at least 20 mm
  • No poorly defined lesions
  • No vague hypervascular patches
  • +21 more criteria

You may not qualify if:

  • No thromboembolic event within the past 12 months
  • No clinically significant cardiovascular disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring parenteral antibiotics
  • No serious non-healing wound/ulcer or bone fracture
  • No variceal bleeding within the past 6 months
  • No malignancy within the past 5 years except localized nonmelanoma skin cancer
  • No ongoing psychiatric or social situation that would preclude study compliance
  • No known hypersensitivity to Chinese hamster ovary cell products
  • No known hypersensitivity to other recombinant human antibodies
  • No more than 1 prior biologic therapy
  • No concurrent interferon
  • No concurrent interleukin-2
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

Location

Related Publications (1)

  • Siegel AB, Cohen EI, Ocean A, Lehrer D, Goldenberg A, Knox JJ, Chen H, Clark-Garvey S, Weinberg A, Mandeli J, Christos P, Mazumdar M, Popa E, Brown RS Jr, Rafii S, Schwartz JD. Phase II trial evaluating the clinical and biologic effects of bevacizumab in unresectable hepatocellular carcinoma. J Clin Oncol. 2008 Jun 20;26(18):2992-8. doi: 10.1200/JCO.2007.15.9947.

    PMID: 18565886RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Lisa Escobar-Peralta, Program Manager
Organization
Montefiore Medical Center
lescobar@montefiore.org
718-379-6866

Study Officials

  • Abby Siegel

    Montefiore Medical Center - Moses Campus

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2003

First Posted

March 7, 2003

Study Start

February 1, 2003

Primary Completion

January 1, 2008

Study Completion

December 1, 2009

Last Updated

February 29, 2016

Results First Posted

February 29, 2016

Record last verified: 2012-12

Locations

US(1)