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A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

NCT00881504 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2014-10-20

Study results available
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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.

Conditions

  • Biliary Tract Cancer

Interventions

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • John L Marshall, MD · Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-02-28
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00881504 on ClinicalTrials.gov