Trial Information

Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma

- Treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. Cycle 1
is only 2 weeks long.

- During cycle one only, bevacizumab will be given intravenously on day one. Two weeks
after receiving bevacizumab, the patient will return to the clinic for treatment with
all 3 study drugs.

- During cycle 2 and every cycle thereafter patients will receive; bevacizumab
intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16;
oxaliplatin intravenously on day 2 and day 16.

- The following evaluations will be conducted on day 1 and day 15 of each cycle (once
every 2 weeks): physical examination, vital signs, medical history, blood tests and
urine tests.

- Tumor measurements done by CT and/or MRI will be repeated at the end of cycle 3 and
every 2 cycles thereafter.

- Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) of the liver and
Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment
during cycle 1, and the Perfusion CT will be repeated at the end of cycle 3.

- Once study treatment is stopped the following evaluations will be performed: physical
exam, vital signs, blood work, urine tests, CT scan of chest, abdomen and pelvis, and
tumor measurements by CT or MRI scans.

- Follow-up will consist of physical examinations and blood tests every 6 months.

- Patients will continue to receive study treatment as long as there is no disease
progression or unacceptable side affects.