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

Stopped early · Phase 3

Conditions studied: Biliary Tract Cancer

In brief

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.

Key facts

Study ID

NCT00090025

Run by

Helsinn Healthcare SA

People needed

248

Starts

2004-09-01

Expected to finish

2006-11-01

Last updated by the study team

2009-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Long Beach VA Medical Center — Long Beach, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Tampa General Hospital — Tampa, Florida, United States
• Winship Cancer Institute, Emory University Hospital — Atlanta, Georgia, United States
• Carle Clinic Association — Urbana, Illinois, United States
• Medical Consultants, PC c/o Ball Cancer Center — Muncie, Indiana, United States
• Oncology Associates — Cedar Rapids, Iowa, United States
• Louisiana Oncology Associates — Lafayette, Louisiana, United States
• Tufts - New England Medical Center — Boston, Massachusetts, United States
• Josephine Ford Cancer Center at Henry Ford Health System — Detroit, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Oncology Care Center PLLC — Saint Joseph, Michigan, United States
• Norris Cotton Cancer Center — Lebanon, New Hampshire, United States
• Queens Hospital Center — Jamaica, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• New York Medical College — Valhalla, New York, United States
• Cancer Treatment and Research Center — Bismarck, North Dakota, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Charleston Hematology Oncology, PA — Charleston, South Carolina, United States
• The Sarah Cannon Cancer Center — Nashville, Tennessee, United States
• University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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