A Phase II Study Of rhuMAb VEGF (BEVACIZUMAB) In Patients With Hepatocellular Carcinoma Receiving Chemoembolization
- 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
- 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
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Neovessel formation as measured by angiogram at 14 weeks
Carolyn Britten, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|