A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

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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