Phase I Study of Proton Radiotherapy and Bevacizumab for Primary Liver Tumors
Proton beams are designed to deliver a high dose of radiation to the abnormal tissues while
sparing surrounding normal tissues. Bevacizumab is a biotherapy that is designed to prevent
or slow down the growth of cancer cells by blocking the growth of blood vessels.
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will have a
complete physical exam. Blood (about 2 tablespoons) and urine will be collected for routine
tests. You will have chest x-rays and a computed tomography (CT) scan of your abdomen
(stomach area) and pelvis. Women who are able to have a children must have a negative urine
You will then have a radiation treatment planning session called a simulation. You will get
a CT scan of your abdomen, and marks will be placed on your skin to help guide the radiation
treatments when you return for the actual treatments. At around the same time, you will
receive your first dose of bevacizumab through a needle in your vein. The infusion will at
first last 90 minutes. If there are no allergic reactions, fevers, or chills, the infusion
will be shortened to 60 minutes and then 30 minutes for later infusions. Your second dose of
bevacizumab will be given with the start of radiation therapy treatments. Your final dose of
bevacizumab will be given 2 weeks later. You will receive radiation therapy once a day, for
5 days in a row (Monday-Friday) for 4 weeks (total of 20 treatments).
During this study, you will have physical exams weekly during treatment, 1 month after the
last proton beam therapy visit and then every 3 months thereafter. Every week, while
receiving proton beam therapy, blood (about 2 teaspoons) will be drawn to check for any
side effects. You will be asked about any side effects you may be experiencing.
You may remain on study for as long as you are benefitting. You will be taken off study if
the disease gets worse or intolerable side effects occur.
After participation in this study is over, you will have follow-up evaluation every 3 months
for 2 years. During these visits, you will have a physical exam. You will have CT scans.
Blood (about 2 teaspoons) will be drawn for routine tests.
This is an investigational study. Bevacizumab is FDA approved and commercially available
for the treatment of metastatic colon cancer. The use of bevacizumab with proton beam
therapy is investigational. Up to 30 patients will take part in this study. All will be
enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity (during and within 1 month after completion of radiotherapy)
1 month +/- 1 week upon completion of concurrent chemoradiation
Sunil Krishnan, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T. M.D. Anderson Cancer Center||Houston, Texas 77030|