Phase II Study of Capecitabine, Oxaliplatin, Bevacizumab and Radiation Therapy in Biliary Tract and Gallbladder Cancer
There are two phases of study treatment. The first phase is for all patients and will last
about 6 weeks. During this phase, oxaliplatin will be given intravenously once a week
during weeks 1, 2, 4, and 5 on days 1, 8, 22, and 29; bevacizumab will be given
intravenously once every 2 weeks during weeks 1, 3, and 5 on days 1, 15, and 29;
capecitabine will be administered orally for 14 consecutive days (days 1-14), then a week of
no capecitabine, followed by another 14 days of capecitabine (days 22-35).
Radiation therapy will be given once daily for 5 days (Monday-Friday) per week for a total
of 28 treatments.
During this first phase of the study the following tests will be performed weekly: physical
exam, vital signs, medical history, blood tests and urine tests.
After the first phase is finished patients will wait 4 weeks then have a CT scan, MRCP,
blood tests and a physical exam to evaluate the status of the disease.
Phase two of the study is broken up into two groups: 1) patients who had tumors removed
prior to entering study and 2) patients who entered the study with advanced disease.
If the patients had tumors removed prior to entering the study, they will be treated again
with all 3 study drugs but no radiation over a 6-week period as they did earlier in the
study. This 6-week regimen will be repeated twice for a total of 12 weeks of treatment.
Patients with advanced disease that could not be removed by surgery when they first entered
the study but the evaluation tests after the first phase show the tumor has responded
(reduced in size) and can now be resected, will have surgery to remove the tumors.
Following surgical recovery (8-10 weeks) they will be treated again with all 3 of the study
drugs but no radiation over a 6-week period as they did earlier in the study. This 6-week
regimen will be repeated twice for a total of 12 weeks of study treatment.
If the evaluation tests show that the patients' cancer has remained stable (not gotten worse
or better) they will be treated again with all three study drugs but no radiation over a
6-week period as they did earlier in the study. This 6-week regimen will be repeated twice
for a total of 12 weeks of study treatment.
During the additional 12 weeks of study treatment a physical exam, vital signs, medical
history, blood testing and urine testing will be performed once every 3 weeks.
At the end of study treatment the following evaluations will be performed: physical exam,
vital signs, blood work, CT scan of the chest and abdomen, MRCP, and tumor measurements by
CT scans. These evaluations will be repeated every 3 months thereafter.
Patients will be removed from the study if their disease worsens or there are unacceptable
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the progression free survival rate at one year for locally advanced, or resected with positive margins, biliary tract and gallbladder cancer patients
Andrew Zhu, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|