XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
- 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
- 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
- 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
Group Intervention Description 5-FU Plus Leucovorin (LV) 5-Fluorouracil Plus Leucovorin 5-Fluorouracil (5-FU) Plus Leucovorin (LV) becatecarin becatecarin becatecarin
- Primary Outcome Measures
Name Time Method To compare survival duration for XL119 and 5-FU/LV treated subjects time to death
- Secondary Outcome Measures
Name Time Method 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 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