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A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma

Phase 2
18 Years
Not Enrolling
Biliary Tract Cancer

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Trial Information

A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma

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.

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

- 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 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/TIA within 6 months

- History of allergy to oxaliplatin, 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

- 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

- 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 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

John L Marshall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University


United States: Institutional Review Board

Study ID:




Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Biliary Tract Cancer
  • Biliary
  • Oxaliplatin
  • Bevacizumab
  • Carcinoma
  • Biliary Tract Neoplasms



Georgetown University Medical Center Washington, District of Columbia  20007