Status:
TERMINATED
A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Sanofi
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 admin...
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 firs...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of non-resectable adenocarcinoma of the biliary tract, including carcinomas of the gallbladder, the intrahepatic or extrahepatic biliary tract, and ampullary cancer
- Measurable or evaluable disease
- Locally advanced disease that is inoperable ot patients who have had disease recurrence after curative surgical attempt
- Ambulatory with an ECOG performance status of 0-1
- Adequate organ and marrow function
- Must agree to avoid pregnancy prior to study entry and throughout the duration of study participation
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Any prior chemotherapy
- Patients who are receiving other investigational agents
- Patients who have received radiotherapy to more than 25% of their bone marrow for any reason
- Peripheral neuropathy \>/= 2
- Known brain metastases, uncontrolled seizure disorder, encephalitis
- Prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension,unstable angina, congestive heart failure of New York Heart Association (NYHA) class 2 or greater, left ventricular ejection fraction less than 50%, clinically significant vascular disease, serious cardiac arrhythmia requiring medication, cardiomyopathy
- History of myocardial infarction, unstable angina or stroke/transient ischemic attack (TIA) within 6 months
- History of allergy to oxaliplatin, 5-fluoruracil (5-FU), Leucovorin, or Bevacizumab
- History of intra-abdominal abscess within 4 weeks of study entry, abdominal fistula, gastrointestinal perforation, active peptic ulcer disease, or inflammatory bowel disease
- Evidence of bleeding diathesis or coagulopathy
- Serious non-healing wound, ulcer, or bone fracture
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of study entry or anticipation of need for major surgery during the course of the study
- Minor surgical procedures such as core biopsies within 7 days before enrollment, chemotherapy port placement within 24 hours
- Patients on full-dose anticoagulants who have out of range international normalized ratio (INR) or active bleeding
- Concurrent malignancy unless the subject has been curatively treated and disease free for \>/= 2 years or the cancer was non-melanoma skin cancer or early cervical cancer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- Known HIV or Hepatitis B or C
- Life expectancy less than 12 weeks
- Pregnant or nursing women
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00881504
Start Date
June 1 2009
End Date
December 1 2011
Last Update
October 20 2014
Active Locations (1)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007