A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

This study has been terminated.
(Lack of adequate accrual to be able to complete trial)
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00881504
First received: April 13, 2009
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Biliary Tract Cancer
Drug: Modified FOLFOX6 and Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety and toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFOX6 and Bevacizumab
Treatment with modified FOLFOX6 and Bevacizumab
Drug: Modified FOLFOX6 and Bevacizumab
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:
  • Eloxatin
  • Avastin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881504

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

No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00881504     History of Changes
Other Study ID Numbers: OX-07-006, 2007-411
Study First Received: April 13, 2009
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Biliary
Oxaliplatin
Bevacizumab

Additional relevant MeSH terms:
Carcinoma
Biliary Tract Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014