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

Tracking Information

First Received Date ^ICMJE

August 19, 2004

Last Updated Date

January 13, 2009

Start Date ^ICMJE

September 2004

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare survival duration for XL119 and 5-FU/LV treated subjects [ Time Frame: time to death ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To compare survival duration for XL119 and 5-FU/LV treated subjects

Change History

Complete list of historical versions of study NCT00090025 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Frame: time to progressive disease ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Biliary Tract Cancer

Intervention ^ICMJE

Drug: becatecarin
Drug: 5-Fluorouracil Plus Leucovorin

Study Arms / Comparison Groups

Experimental: becatecarin
Active Comparator: 5-Fluorouracil (5-FU) Plus Leucovorin (LV)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

248

Completion Date

November 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00090025

Responsible Party

Helsinn Healthcare SA, Pharma Company Sponsor

Study ID Numbers ^ICMJE

XL119-001

Study Sponsor ^ICMJE

Helsinn Healthcare SA

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Afshin Dowlati, MD

Case Western Reserve University - Cleveland

Information Provided By

Helsinn Healthcare SA

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP