XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors

January 13, 2009 updated by: Helsinn Healthcare SA

A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery

The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 3

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

  • Belgium
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Centre
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Ottawa, Ontario, Canada
        • Ottawa Regional Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital
      • Montreal, Quebec, Canada
        • Centre hospitalier université de Montréal
  • France
      • Besancon cedex, France, 25030
        • CHU - Hospital Jean Minjoz
      • Boulogne Billancourt, France, 92100
        • Hospital Ambroise Paré
      • Lille cedex, France, BP 307 - 59020
        • Centre Oscar Lambret
      • Villejuif Cedex, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, D-13353
        • Charite Berlin der Humbold Universitat
      • Dusseldorf, Germany, D-40225
        • Heinrich-Heine-Universitat-Dusseldorf
      • Hamburg, Germany, D-20099
        • Allgem. Krankenhaus St. Georg
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover
      • Mainz, Germany, D-55131
        • Universitätsklinikum Johannes Gutenberg
      • Munich, Germany, 81675
        • Technischen Universitat Munchen
      • Munich, Germany
        • Klinikum Grosshadern der Ludwig Maximilians Universitaet
      • Tübingen, Germany, D-72076
        • Universitätsklinikum Tübingen
      • Ulm, Germany, D-89081
        • Universitätsklinikum Ulm
  • Hungary
      • Budapest, Hungary
        • Orszagos Onkologiai Intezet
  • Italy
      • Aviano, Italy
        • Centro di Riferimento Oncologico di Aviano
      • Livorno, Italy, 57128
        • Ospidale Civile di Livorno
      • Udine, Italy, 33100
        • Policlinico Universitario di Udine
  • Poland
      • Warszawa, Poland, 02-781
        • Centrum Onkologii - Instytut im. Marii
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Cancer Research Center named after N.N. Blokhin, RAMS
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial (Oncology Department)
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Malaga, Spain
        • Hospital Regional Universitario Carlos Haya
      • Pontevedra, Spain
        • Hospital Provincial de Pontevedra
      • Zaragoza, Spain, 50009
        • Hospital Lozano Blesa
  • United Kingdom
    • England
      • Leicester, England, United Kingdom
        • Leicester Royal Infirmary
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
      • San Francisco, California, United States, 94115
        • Pacific Hematology Oncology Associates
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Florida
      • Tampa,, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University Hospital
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Clinic Association
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Medical Consultants, PC c/o Ball Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Louisiana Oncology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • TUFTS - New England Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center at Henry Ford Health System
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • St. Joseph, Michigan, United States, 49085
        • Oncology Care Center PLLC
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Norris Cotton Cancer Center
    • New York
      • Jamaica, New York, United States, 11432
        • Queens Hospital Center
      • Syracuse, New York, United States, 13210
        • Suny Upstate Medical University
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Dakota
      • Bismark, North Dakota, United States, 58501
        • Cancer Treatment and Research Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology, PA
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Cancer Center
    • Washington
      • Lacey, Washington, United States, 98503
        • Western Washington Oncology, Inc.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer 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:

  • Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach
  • 18 years or older
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
  • Willing and able to sign informed consent
  • Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide)
  • Women of child-bearing age must have a negative pregnancy test
  • Laboratory criteria

Exclusion Criteria:

  • Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)
  • Unstable angina, or class III or IV New York Heart Association heart disease
  • Central nervous system metastases
  • Uncontrolled diabetes mellitus
  • Uncontrolled seizure disorder
  • Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment
  • Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation
  • Pregnant or breast-feeding
  • A known history of human immunodeficiency virus (HIV) infection

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: becatecarin
Drug: becatecarin
Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle
Other Names:
  • XL119
ACTIVE_COMPARATOR: 5-FU Plus Leucovorin (LV)
5-Fluorouracil (5-FU) Plus Leucovorin (LV)
Drug: 5-Fluorouracil Plus Leucovorin
5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare survival duration for XL119 and 5-FU/LV treated subjects
Time Frame: time to death
time to death

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine time to progressive disease for XL119 and 5-FU/LV treated subjects, to evaluate clinical benefit for XL119 and 5-FU/LV treated subjects, and to assess the safety profile of XL119
Time Frame: time to progressive disease
time to progressive disease

Collaborators and Investigators

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

Sponsor

Helsinn Healthcare SA

Investigators

  • Study Chair: Afshin Dowlati, MD, Case Western Reserve University - Cleveland

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

September 1, 2004

Primary Completion (ACTUAL)

November 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

August 19, 2004

First Submitted That Met QC Criteria

August 20, 2004

First Posted (ESTIMATE)

August 23, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 13, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL119-001

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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