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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00090025

Enrollment

248

Registered

2004-08-23

Start date

2004-09-30

Completion date

2006-11-30

Last updated

2009-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

Keywords

Advanced Biliary Cancer, Cholangiocarcinoma, Gall bladder tumor, Gall bladder cancer, Bile duct tumor, Tumor of biliary tree

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 tumors.

Interventions

DRUGbecatecarin

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

DRUG5-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To compare survival duration for XL119 and 5-FU/LV treated subjects	time to death

Secondary

Measure	Time frame
To determine time to progressive disease for XL119 and 5-FU/LV treated subjects, to evaluate clinical benefit for XL119 and 5-FU/LV treated subjects, and to assess the safety profile of XL119	time to progressive disease

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026