A Study of FOLFOX6 With Bevacizumab for 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma|
- Progression-free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Safety and toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: FOLFOX6 and Bevacizumab
Treatment with modified FOLFOX6 and Bevacizumab
Drug: Modified FOLFOX6 and Bevacizumab
Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks
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.
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||John L Marshall, MD||Georgetown University|