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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090025
Recruitment Status : Terminated (Futility reasons after Independent Data Monitoring Committee interim analysis)
First Posted : August 23, 2004
Last Update Posted : January 14, 2009
Information provided by:
Helsinn Healthcare SA

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: becatecarin Drug: 5-Fluorouracil Plus Leucovorin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. To compare survival duration for XL119 and 5-FU/LV treated subjects [ Time Frame: time to death ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090025

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Sponsors and Collaborators
Helsinn Healthcare SA
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Study Chair: Afshin Dowlati, MD Case Western Reserve University - Cleveland
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Responsible Party: Helsinn Healthcare SA, Pharma Company Sponsor Identifier: NCT00090025    
Other Study ID Numbers: XL119-001
First Posted: August 23, 2004    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009
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:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances