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A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00881504
Recruitment Status : Terminated (It was not possible to get insurance companies to cover bevacizumab.)
First Posted : April 15, 2009
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Information provided by (Responsible Party):
Georgetown University

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: "Bevacizumab" in combination with "modified FOLFOX6". Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma
Study Start Date : June 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Safety and Toxicity [ Time Frame: 8 weeks ]
    The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00881504

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United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
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Principal Investigator: John L Marshall, MD Georgetown University

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Responsible Party: Georgetown University Identifier: NCT00881504     History of Changes
Other Study ID Numbers: OX-07-006
2007-411 ( Other Identifier: IRB )
First Posted: April 15, 2009    Key Record Dates
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014
Last Verified: September 2014

Keywords provided by Georgetown University:

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors