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

Primary Purpose

Biliary Tract Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
becatecarin
5-Fluorouracil Plus Leucovorin
Sponsored by
Helsinn Healthcare SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Cancer focused on measuring Advanced Biliary Cancer, Cholangiocarcinoma, Gall bladder tumor, Gall bladder cancer, Bile duct tumor, Tumor of biliary tree

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Long Beach VA Medical Center
  • University of California, Irvine Medical Center
  • Sharp Clinical Oncology Research
  • Pacific Hematology Oncology Associates
  • Yale University School of Medicine
  • Tampa General Hospital
  • Winship Cancer Institute, Emory University Hospital
  • Carle Clinic Association
  • Medical Consultants, PC c/o Ball Cancer Center
  • Oncology Associates
  • Louisiana Oncology Associates
  • Tufts - New England Medical Center
  • Josephine Ford Cancer Center at Henry Ford Health System
  • West Michigan Cancer Center
  • Oncology Care Center PLLC
  • Norris Cotton Cancer Center
  • Queens Hospital Center
  • SUNY Upstate Medical University
  • New York Medical College
  • Cancer Treatment and Research Center
  • Gabrail Cancer Center
  • Case Western Reserve University
  • Charleston Hematology Oncology, PA
  • The Sarah Cannon Cancer Center
  • Western Washington Oncology, Inc.
  • University of Wisconsin Comprehensive Cancer Center
  • Universitair Ziekenhuis Gent
  • British Columbia Cancer Agency - Vancouver Centre
  • London Regional Cancer Centre
  • Ottawa Regional Cancer Centre
  • Centre Hospitalier Universite de Montreal
  • Jewish General Hospital
  • CHU - Hospital Jean Minjoz
  • Hospital Ambroise Pare
  • Centre Oscar Lambret
  • Institut Gustave Roussy
  • Charite Berlin der Humbold Universitat
  • Heinrich-Heine-Universitat-Dusseldorf
  • Allgem. Krankenhaus St. Georg
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Johannes Gutenberg
  • Technischen Universitat Munchen
  • Klinikum Grosshadern der Ludwig Maximilians Universitaet
  • Universitätsklinikum Tübingen
  • Universitatsklinikum Ulm
  • Orszagos Onkologiai Intezet
  • Centro di Riferimento Oncologico di Aviano
  • Ospidale Civile di Livorno
  • Policlinico Universitario di Udine
  • Centrum Onkologii - Instytut im. Marii
  • Cancer Research Center named after N.N. Blokhin, RAMS
  • Hospital Clinic i Provincial (Oncology Department)
  • Hospital Clínico San Carlos
  • Hospital 12 de Octubre
  • Hospital Regional Universitario Carlos Haya
  • Hospital Provincial de Pontevedra
  • Hospital Lozano Blesa
  • Leicester Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

becatecarin

5-FU Plus Leucovorin (LV)

Arm Description

becatecarin

5-Fluorouracil (5-FU) Plus Leucovorin (LV)

Outcomes

Primary Outcome Measures

To compare survival duration for XL119 and 5-FU/LV treated subjects

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2004
Last Updated
January 13, 2009
Sponsor
Helsinn Healthcare SA
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1. Study Identification

Unique Protocol Identification Number
NCT00090025
Brief Title
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
Futility reasons after Independent Data Monitoring Committee interim analysis
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Helsinn Healthcare SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer
Keywords
Advanced Biliary Cancer, Cholangiocarcinoma, Gall bladder tumor, Gall bladder cancer, Bile duct tumor, Tumor of biliary tree

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
becatecarin
Arm Type
Experimental
Arm Description
becatecarin
Arm Title
5-FU Plus Leucovorin (LV)
Arm Type
Active Comparator
Arm Description
5-Fluorouracil (5-FU) Plus Leucovorin (LV)
Intervention Type
Drug
Intervention Name(s)
becatecarin
Other Intervention Name(s)
XL119
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil Plus Leucovorin
Intervention Description
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
Primary Outcome Measure Information:
Title
To compare survival duration for XL119 and 5-FU/LV treated subjects
Time Frame
time to death
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin Dowlati, MD
Organizational Affiliation
Case Western Reserve University - Cleveland
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Long Beach VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Tampa General Hospital
City
Tampa,
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Winship Cancer Institute, Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Carle Clinic Association
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Medical Consultants, PC c/o Ball Cancer Center
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Louisiana Oncology Associates
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Oncology Care Center PLLC
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Queens Hospital Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Cancer Treatment and Research Center
City
Bismark
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Charleston Hematology Oncology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
The Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Western Washington Oncology, Inc.
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
Country
Belgium
Facility Name
British Columbia Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Centre Hospitalier Universite de Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHU - Hospital Jean Minjoz
City
Besancon cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Hospital Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Centre Oscar Lambret
City
Lille cedex
ZIP/Postal Code
BP 307 - 59020
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Charite Berlin der Humbold Universitat
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Heinrich-Heine-Universitat-Dusseldorf
City
Dusseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
Allgem. Krankenhaus St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Universitätsklinikum Johannes Gutenberg
City
Mainz
ZIP/Postal Code
D-55131
Country
Germany
Facility Name
Technischen Universitat Munchen
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Grosshadern der Ludwig Maximilians Universitaet
City
Munich
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
Country
Hungary
Facility Name
Centro di Riferimento Oncologico di Aviano
City
Aviano
Country
Italy
Facility Name
Ospidale Civile di Livorno
City
Livorno
ZIP/Postal Code
57128
Country
Italy
Facility Name
Policlinico Universitario di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Centrum Onkologii - Instytut im. Marii
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Cancer Research Center named after N.N. Blokhin, RAMS
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Hospital Clinic i Provincial (Oncology Department)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya
City
Malaga
Country
Spain
Facility Name
Hospital Provincial de Pontevedra
City
Pontevedra
Country
Spain
Facility Name
Hospital Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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