Trial | NCT00090025  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    248
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.
Study Started
Sep 30
2004
Primary Completion
Nov 30
2006
Study Completion
Nov 30
2006
Last Update
Jan 14
2009
Estimate

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

  • Other names: XL119

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

becatecarin Experimental

becatecarin

5-FU Plus Leucovorin (LV) Active Comparator

5-Fluorouracil (5-FU) Plus Leucovorin (LV)

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
No Results Posted