Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT00881504
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00881504
Study Brief:
Protocol Section:
NCT00881504