A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma
This is a single-center, open labeled, single-arm study in patients with previously
untreated unresectable biliary tract cancer. This trial will follow a Simon's two-stage
optimal design. For the first stage, 9 patients will be accrued. If none of the 9 patients
have controlled disease with mFOLFOX6 in combination with bevacizumab, the combination will
be rejected and the trial stopped. However, if at least 1 patient of the 9 (11%) respond to
treatment in the first stage, then an additional 15 patients will be entered into the second
stage, for a total of 24 patients in the phase II study. If 3 (13%) or more patients
respond to therapy, then the combination will be considered for further investigation.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival
2 years
No
John L Marshall, MD
Principal Investigator
Georgetown University
United States: Institutional Review Board
OX-07-006
NCT00881504
June 2009
December 2011
Name | Location |
---|---|
Georgetown University Medical Center | Washington, District of Columbia 20007 |