A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2009 |
| End Date: | December 2011 |
A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma
This study is for patients with biliary tract cancer that has spread and who are not
candidates for surgical resection.
The purpose of this research is to determine if bevacizumab can be safely administered with
Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on
biliary cancer.
In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent,
bevacizumab will be tested.
Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their
disease gets worse or they are unable to tolerate treatment.
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.
We found this trial at
1
site
4000 Reservoir Road NW, Suite 120
Washington, Washington DC 20007
Washington, Washington DC 20007
(202) 687-0100
Georgetown Univ Med Ctr Georgetown University Medical Center is committed to excellence in research, education...
Click here to add this to my saved trials
