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

Information source: Helsinn Healthcare SA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Biliary Tract Cancer

Intervention: becatecarin (Drug); 5-Fluorouracil Plus Leucovorin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Helsinn Healthcare SA

Official(s) and/or principal investigator(s):
Afshin Dowlati, MD, Study Chair, Affiliation: Case Western Reserve University - Cleveland


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: 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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Universitair Ziekenhuis Gent, Ghent, Belgium

CHU - Hospital Jean Minjoz, Besancon cedex 25030, France

Hospital Ambroise Pare, Boulogne Billancourt 92100, France

Centre Oscar Lambret, Lille cedex BP 307 - 59020, France

Institut Gustave Roussy, Villejuif Cedex 94805, France

Charite Berlin der Humbold Universitat, Berlin D-13353, Germany

Heinrich-Heine-Universitat-Dusseldorf, Dusseldorf D-40225, Germany

Allgem. Krankenhaus St. Georg, Hamburg D-20099, Germany

Medizinische Hochschule Hannover, Hannover D-30625, Germany

Universitätsklinikum Johannes Gutenberg, Mainz D-55131, Germany

Klinikum Grosshadern der Ludwig Maximilians Universitaet, Munich, Germany

Technischen Universitat Munchen, Munich 81675, Germany

Universitätsklinikum Tübingen, Tübingen D-72076, Germany

Universitatsklinikum Ulm, Ulm D-89081, Germany

Orszagos Onkologiai Intezet, Budapest, Hungary

Centro di Riferimento Oncologico di Aviano, Aviano, Italy

Ospidale Civile di Livorno, Livorno 57128, Italy

Policlinico Universitario di Udine, Udine 33100, 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 12 de Octubre, Madrid 28041, Spain

Hospital Clínico San Carlos, Madrid 28040, Spain

Hospital Regional Universitario Carlos Haya, Malaga, Spain

Hospital Provincial de Pontevedra, Pontevedra, Spain

Hospital Lozano Blesa, Zaragoza 50009, 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

Long Beach VA Medical Center, Long Beach, California 90822, United States

University of California, Irvine Medical Center, Orange, California 92868, United States

Sharp Clinical Oncology Research, San Diego, California 92123, United States

Pacific Hematology Oncology Associates, San Francisco, California 94115, 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

Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan 48202, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States

Oncology Care Center PLLC, St. Joseph, Michigan 49085, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire 03756, United States

Queens Hospital Center, Jamaica, New York 11432, United States

SUNY Upstate Medical University, Syracuse, New York 13210, United States

New York Medical College, Valhalla, New York 10595, 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

Centre Hospitalier Universite de Montreal, Montreal, Quebec, Canada

Jewish General Hospital, 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

Additional Information

Starting date: September 2004
Last updated: January 13, 2009

Page last updated: August 23, 2015

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