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

This study has been terminated.
(Futility reasons after Independent Data Monitoring Committee interim analysis)
Information provided by:
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
First received: August 19, 2004
Last updated: January 13, 2009
Last verified: January 2009
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.

Condition Intervention Phase
Biliary Tract Cancer
Drug: becatecarin
Drug: 5-Fluorouracil Plus Leucovorin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Helsinn Healthcare SA:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 248
Study Start Date: September 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: becatecarin
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 Name: XL119
Active Comparator: 5-FU Plus Leucovorin (LV)
5-Fluorouracil (5-FU) Plus Leucovorin (LV)
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090025

  Show 59 Study Locations
Sponsors and Collaborators
Helsinn Healthcare SA
Study Chair: Afshin Dowlati, MD Case Western Reserve University - Cleveland
  More Information

Responsible Party: Helsinn Healthcare SA, Pharma Company Sponsor
ClinicalTrials.gov Identifier: NCT00090025     History of Changes
Other Study ID Numbers: XL119-001 
Study First Received: August 19, 2004
Last Updated: January 13, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Canada: Health Canada
Canada: Ethics Review Committee
Germany: Ministry of Health
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Spain: Ministry of Health
Spain: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Helsinn Healthcare SA:
Advanced Biliary Cancer
Gall bladder tumor
Gall bladder cancer
Bile duct tumor
Tumor of biliary tree

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016