NCT00090025

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

A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	becatecarin	Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle
DRUG	5-Fluorouracil Plus Leucovorin	5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2004-08-23
• Last updated: 2009-01-14

Locations

59 sites across 11 countries: United States, Belgium, Canada, France, Germany, Hungary, Italy, Poland, Russia, Spain, United Kingdom