Brief Title
A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
Official Title
A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free Survival
Secondary Outcome
Safety and Toxicity
Condition
Biliary Tract Cancer
Intervention
"Bevacizumab" in combination with "modified FOLFOX6".
Study Arms / Comparison Groups
"FOLFOX6" and "Bevacizumab"
Description: Intervention = "bevacizumab" in combination with chemotherapy Treatment of biliary system carcinoma using "Bevacizumab" in combination with "modified FOLFOX6".
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
June 2009
Completion Date
December 2011
Primary Completion Date
February 2011
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
John L Marshall, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00881504
Organization ID
OX-07-006
Secondary IDs
2007-411
Responsible Party
Sponsor
Study Sponsor
Georgetown University
Collaborators
Sanofi
Study Sponsor
John L Marshall, MD, Principal Investigator, Georgetown University
Verification Date
September 2014