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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT00049322
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    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 Details

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.

Key Dates

First listed
Jan 27, 2003
Start date
Jun 30, 2003
Status verified
Feb 2016
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I-bevacizumab
    Patients 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.
  • No Intervention: Arm II-chemoembolization
    chemoembolization as part of standard of care

Primary Outcome Measure

Neovessel Formation as Measured by Angiogram at 14 Weeks [ Time Frame: 14 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jonsson Comprehensive Cancer Center at UCLALos AngelesCalifornia90095-1781-

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