MedTrace Logo

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

NCT00090025 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2009-01-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Helsinn Healthcare SA

    lead INDUSTRY

Principal Investigators

  • Afshin Dowlati, MD · Case Western Reserve University - Cleveland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00090025 on ClinicalTrials.gov