XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
- Conditions
- Biliary Tract Cancer
- Interventions
- Registration Number
- NCT00090025
- Lead Sponsor
- Helsinn Healthcare SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 248
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5-FU Plus Leucovorin (LV) 5-Fluorouracil Plus Leucovorin 5-Fluorouracil (5-FU) Plus Leucovorin (LV) becatecarin becatecarin becatecarin
- Primary Outcome Measures
Name Time Method To compare survival duration for XL119 and 5-FU/LV treated subjects time to death
- Secondary Outcome Measures
Name Time Method 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 to progressive disease
Trial Locations
- Locations (59)
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Policlinico Universitario di Udine
🇮🇹Udine, Italy
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Heinrich-Heine-Universitat-Dusseldorf
🇩🇪Dusseldorf, Germany
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Winship Cancer Institute, Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Charleston Hematology Oncology, PA
🇺🇸Charleston, South Carolina, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Long Beach VA Medical Center
🇺🇸Long Beach, California, United States
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Hospital Provincial de Pontevedra
🇪🇸Pontevedra, Spain
Centre Hospitalier Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Medical Consultants, PC c/o Ball Cancer Center
🇺🇸Muncie, Indiana, United States
Cancer Treatment and Research Center
🇺🇸Bismark, North Dakota, United States
Oncology Care Center PLLC
🇺🇸St. Joseph, Michigan, United States
Universitatsklinikum Ulm
🇩🇪Ulm, Germany
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Ospidale Civile di Livorno
🇮🇹Livorno, Italy
CHU - Hospital Jean Minjoz
🇫🇷Besancon cedex, France
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Tampa General Hospital
🇺🇸Tampa,, Florida, United States
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Carle Clinic Association
🇺🇸Urbana, Illinois, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
Centro di Riferimento Oncologico di Aviano
🇮🇹Aviano, Italy
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Hospital ClÃnico San Carlos
🇪🇸Madrid, Spain
Queens Hospital Center
🇺🇸Jamaica, New York, United States
Cancer Research Center named after N.N. Blokhin, RAMS
🇷🇺Moscow, Russian Federation
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Sharp Clinical Oncology Research
🇺🇸San Diego, California, United States
Josephine Ford Cancer Center at Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Pacific Hematology Oncology Associates
🇺🇸San Francisco, California, United States
The Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Universitätsklinikum Johannes Gutenberg
🇩🇪Mainz, Germany
Klinikum Grosshadern der Ludwig Maximilians Universitaet
🇩🇪Munich, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Allgem. Krankenhaus St. Georg
🇩🇪Hamburg, Germany
Technischen Universitat Munchen
🇩🇪Munich, Germany
Charite Berlin der Humbold Universitat
🇩🇪Berlin, Germany
Hospital Ambroise Pare
🇫🇷Boulogne Billancourt, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
Western Washington Oncology, Inc.
🇺🇸Lacey, Washington, United States
Centre Oscar Lambret
🇫🇷Lille cedex, France
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Hospital Lozano Blesa
🇪🇸Zaragoza, Spain
Orszagos Onkologiai Intezet
ðŸ‡ðŸ‡ºBudapest, Hungary
Hospital Clinic i Provincial (Oncology Department)
🇪🇸Barcelona, Spain
Centrum Onkologii - Instytut im. Marii
🇵🇱Warszawa, Poland
British Columbia Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States