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

Sponsor:	Helsinn Healthcare SA
Information provided by:	Helsinn Healthcare SA
ClinicalTrials.gov Identifier:	NCT00090025

Purpose

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.

Condition	Intervention	Phase
Biliary Tract Cancer	Drug: becatecarin Drug: 5-Fluorouracil Plus Leucovorin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor BMS 181176 Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:

To compare survival duration for XL119 and 5-FU/LV treated subjects [ Time Frame: time to death ] [ Designated as safety issue: No ]

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 [ Time Frame: time to progressive disease ] [ Designated as safety issue: No ]

Enrollment:	248
Study Start Date:	September 2004
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
becatecarin: Experimental becatecarin	Drug: becatecarin 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
5-FU Plus Leucovorin (LV): Active Comparator 5-Fluorouracil (5-FU) Plus Leucovorin (LV)	Drug: 5-Fluorouracil Plus Leucovorin 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090025

Hide Study Locations

Locations

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

Sponsors and Collaborators

Helsinn Healthcare SA

Investigators

Study Chair:

Afshin Dowlati, MD

Case Western Reserve University - Cleveland

More Information

No publications provided

Responsible Party:	Pharma Company Sponsor ( Helsinn Healthcare SA )
Study ID Numbers:	XL119-001
Study First Received:	August 19, 2004
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00090025 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Canada: Health Canada; Canada: Ethics Review Committee; Germany: Ministry of Health; Germany: Ethics Commission; Hungary: National Institute of Pharmacy; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Russia: Ethics Committee; Spain: Ministry of Health; Spain: Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Helsinn Healthcare SA:

Advanced Biliary Cancer
Cholangiocarcinoma
Gall bladder tumor

Gall bladder cancer
Bile duct tumor
Tumor of biliary tree

Additional relevant MeSH terms:

Antimetabolites
Vitamin B Complex
Biliary Tract Neoplasms
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Leucovorin

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Vitamins
Therapeutic Uses
Biliary Tract Diseases
Fluorouracil
Micronutrients

ClinicalTrials.gov processed this record on November 27, 2009