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

Phase 3
Terminated
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
5-FU Plus Leucovorin (LV)5-Fluorouracil Plus Leucovorin5-Fluorouracil (5-FU) Plus Leucovorin (LV)
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Primary Outcome Measures
NameTimeMethod
To compare survival duration for XL119 and 5-FU/LV treated subjectstime to death
Secondary Outcome Measures
NameTimeMethod
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 XL119time to progressive disease

Trial Locations

Locations (59)

University of Alabama at Birmingham Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

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

Scroll for more (49 remaining)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

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