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 — BIOLOGICALGiven 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-bevacizumabPatients 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-chemoembolizationchemoembolization as part of standard of care
Primary Outcome Measure
Neovessel Formation as Measured by Angiogram at 14 Weeks [ Time Frame: 14 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | - |
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