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.
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 (within 72 hours of first XL119 treatment)
- white blood cell count (WBC) >3000/ µL
- absolute neutrophil count ≥1500/µL
- hemoglobin≥9. 5 g/dL
- platelet count ≥100,000/µL
- lymphocyte count <20,000/µL
- normal blood urea nitrogen (BUN)
- serum creatinine within 2. 5 times the upper limit of normal
- alanine transaminase (ALT) within 2. 5 times the upper limit of normal
- aspartate transaminase (AST) within 2. 5 times the upper limit of normal
- bilirubin <3 mg/dL
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
Universitair Ziekenhuis Gent, Ghent, Belgium
Centre Oscar Lambret, Lille cedex BP 307 - 59020, France
Institut Gustave Roussy, Villejuif Cedex 94805, France
Hospital Ambroise Pare, Boulogne Billancourt 92100, France
CHU - Hospital Jean Minjoz, Besancon cedex 25030, France
Allgem. Krankenhaus St. Georg, Hamburg D-20099, Germany
Heinrich-Heine-Universitat-Dusseldorf, Dusseldorf D-40225, Germany
Medizinische Hochschule Hannover, Hannover D-30625, Germany
Universitatsklinikum Ulm, Ulm D-89081, Germany
Charite Berlin der Humbold Universitat, Berlin D-13353, Germany
Universitätsklinikum Johannes Gutenberg, Mainz D-55131, Germany
Universitätsklinikum Tübingen, Tübingen D-72076, Germany
Technischen Universitat Munchen, Munich 81675, Germany
Klinikum Grosshadern der Ludwig Maximilians Universitaet, Munich, Germany
Orszagos Onkologiai Intezet, Budapest, Hungary
Ospidale Civile di Livorno, Livorno 57128, Italy
Policlinico Universitario di Udine, Udine 33100, Italy
Centro di Riferimento Oncologico di Aviano, Aviano, Italy
Centrum Onkologii - Instytut im. Marii, Warszawa 02-781, Poland
Cancer Research Center named after N.N. Blokhin, RAMS, Moscow 115478, Russian Federation
Hospital Clinic i Provincial (Oncology Department), Barcelona 08036, Spain
Hospital Regional Universitario Carlos Haya, Malaga, Spain
Hospital Provincial de Pontevedra, Pontevedra, Spain
Hospital Lozano Blesa, Zaragoza 50009, Spain
Hospital 12 de Octubre, Madrid 28041, Spain
Hospital Clínico San Carlos, Madrid 28040, Spain
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294, United States
British Columbia Cancer Agency – Vancouver Centre, Vancouver, British Columbia V5Z 4E6, Canada
Pacific Hematology Oncology Associates, San Francisco, California 94115, United States
Long Beach VA Medical Center, Long Beach, California 90822, United States
Sharp Clinical Oncology Research, San Diego, California 92123, United States
University of California, Irvine Medical Center, Orange, California 92868, United States
Yale University School of Medicine, New Haven, Connecticut 06520, United States
Leicester Royal Infirmary, Leicester, England, United Kingdom
Tampa General Hospital, Tampa,, Florida 33606, United States
Winship Cancer Institute, Emory University Hospital, Atlanta, Georgia 30322, United States
Carle Clinic Association, Urbana, Illinois 61801, United States
Medical Consultants, PC c/o Ball Cancer Center, Muncie, Indiana 47303, United States
Oncology Associates, Cedar Rapids, Iowa 52403, United States
Louisiana Oncology Associates, Lafayette, Louisiana 70506, United States
Tufts – New England Medical Center, Boston, Massachusetts 02111, United States
Oncology Care Center PLLC, St. Joseph, Michigan 49085, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan 48202, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire 03756, United States
Queens Hospital Center, Jamaica, New York 11432, United States
New York Medical College, Valhalla, New York 10595, United States
SUNY Upstate Medical University, Syracuse, New York 13210, United States
Cancer Treatment and Research Center, Bismark, North Dakota 58501, United States
Gabrail Cancer Center, Canton, Ohio 44718, United States
Case Western Reserve University, Cleveland, Ohio 44106, United States
London Regional Cancer Centre, London, Ontario N6A 4L6, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Centre Hospitalier Universite de Montreal, Montreal, Quebec, Canada
Charleston Hematology Oncology, PA, Charleston, South Carolina 29403, United States
The Sarah Cannon Cancer Center, Nashville, Tennessee 37203, United States
Western Washington Oncology, Inc., Lacey, Washington 98503, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, United States
