Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Unresectable or Metastatic Biliary Tract and Gallbladder Cancer
- The chemotherapy drugs are given twice every 28 days. This 28 day period is called a
cycle of study treatment.
- Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15.
Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of
each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of
- The following tests and procedures will be performed on day 1 and day 15 or each cycle:
physical examination; medical history; blood work; and urine test. A PET scan will be
repeated at the end of cycle 2 and CT scans will be repeated once every 8 weeks.
- Participants will continue to receive cycles of study treatment as long as their
disease does not progress and they are not experiencing any serious side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the progression free survival of GEMOX-B regimen in patients with unresectable or metastatic biliary tract and gallbladder adenocarcinoma.
Andrew X. Zhu, MD
Massachusetts General Hospital
United States: Food and Drug Administration