A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

October 16, 2014 updated by: Georgetown University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • Avastin
  • Eloxatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Toxicity
Time Frame: 8 weeks
The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 13, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OX-07-006
  • 2007-411 (Other Identifier: IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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