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.
|Biliary Tract Cancer||Drug: "Bevacizumab" in combination with "modified FOLFOX6".||Phase 2|
|Study Design:||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 ]Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.
- Safety and Toxicity [ Time Frame: 8 weeks ]The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.
|Study Start Date:||June 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: "FOLFOX6" and "Bevacizumab"
Intervention = "bevacizumab" in combination with chemotherapy
Treatment of biliary system carcinoma using "Bevacizumab" in combination with "modified FOLFOX6".
Drug: "Bevacizumab" in combination with "modified FOLFOX6".
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881504
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||John L Marshall, MD||Georgetown University|