A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
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|ClinicalTrials.gov Identifier: NCT00881504|
Recruitment Status : Terminated (It was not possible to get insurance companies to cover bevacizumab.)
First Posted : April 15, 2009
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer||Drug: "Bevacizumab" in combination with "modified FOLFOX6".||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||December 2011|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|