Status:
TERMINATED
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
Lead Sponsor:
Helsinn Healthcare SA
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00090025
Start Date
September 1 2004
End Date
November 1 2006
Last Update
January 14 2009
Active Locations (59)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Long Beach VA Medical Center
Long Beach, California, United States, 90822
3
University of California, Irvine Medical Center
Orange, California, United States, 92868
4
Sharp Clinical Oncology Research
San Diego, California, United States, 92123