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

• Status: Terminated
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinn Healthcare SA
• Treatments: Fluorouracil; Leucovorin

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