Clinical trial NCT00090025: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Biliary Tract Cancer
Keywords: Advanced Biliary Cancer
Cholangiocarcinoma
Gall bladder tumor
Gall bladder cancer
Bile duct tumor
Tumor of biliary tree
Lead sponsor: Helsinn Healthcare SA
Sponsor class: INDUSTRY
First posted: 2004-08-23
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To compare survival duration for XL119 and 5-FU/LV treated subjects
timeFrame: time to death
Secondary outcomes:
measure: 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
timeFrame: time to progressive disease
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Tampa,
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University Hospital
state: Georgia
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Muncie
country: United States
facility: Medical Consultants, PC c/o Ball Cancer Center
state: Indiana
city: Cedar Rapids
country: United States
facility: Oncology Associates
state: Iowa
city: Lafayette
country: United States
facility: Louisiana Oncology Associates
state: Louisiana
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Health System
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: St. Joseph
country: United States
facility: Oncology Care Center PLLC
state: Michigan
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Bismark
country: United States
facility: Cancer Treatment and Research Center
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Charleston
country: United States
facility: Charleston Hematology Oncology, PA
state: South Carolina
city: Nashville
country: United States
facility: The Sarah Cannon Cancer Center
state: Tennessee
city: Lacey
country: United States
facility: Western Washington Oncology, Inc.
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
state: British Columbia
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Besancon cedex
country: France
facility: CHU - Hospital Jean Minjoz
city: Boulogne Billancourt
country: France
facility: Hospital Ambroise Pare
city: Lille cedex
country: France
facility: Centre Oscar Lambret
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite Berlin der Humbold Universitat
city: Dusseldorf
country: Germany
facility: Heinrich-Heine-Universitat-Dusseldorf
city: Hamburg
country: Germany
facility: Allgem. Krankenhaus St. Georg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Mainz
country: Germany
facility: Universitätsklinikum Johannes Gutenberg
city: Munich
country: Germany
facility: Technischen Universitat Munchen
city: Munich
country: Germany
facility: Klinikum Grosshadern der Ludwig Maximilians Universitaet
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
city: Livorno
country: Italy
facility: Ospidale Civile di Livorno
city: Udine
country: Italy
facility: Policlinico Universitario di Udine
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii
city: Moscow
country: Russian Federation
facility: Cancer Research Center named after N.N. Blokhin, RAMS
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial (Oncology Department)
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Pontevedra
country: Spain
facility: Hospital Provincial de Pontevedra
city: Zaragoza
country: Spain
facility: Hospital Lozano Blesa
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
Study officials:
affiliation: Case Western Reserve University - Cleveland
name: Afshin Dowlati, MD
role: STUDY_CHAIR
References: