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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.
Andrew Zhu, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|