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

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

This study has been terminated.

Study NCT00090025. Last updated on January 2, 2007. Information provided by Helsinn Healthcare SA

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
Official Title ^†	A Phase 3 Multicenter, Single-Blind, 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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	To compare survival duration for XL119 and 5-FU/LV treated subjects
Secondary Outcome Measure ^†	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
Condition ^†	Biliary Tract Cancer
Intervention ^†	Drug: XL119 Drug: 5-Fluorouracil and Leucovorin
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Terminated
Enrollment ^†	600
Start Date ^†	September 2004
Completion Date	January 2007
Eligibility 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 (within 72 hours of first XL119 treatment) white blood cell count (WBC) >3000/ µL absolute neutrophil count ≥1500/µL hemoglobin≥9.5 g/dL platelet count ≥100,000/µL lymphocyte count <20,000/µL normal blood urea nitrogen (BUN) serum creatinine within 2.5 times the upper limit of normal alanine transaminase (ALT) within 2.5 times the upper limit of normal aspartate transaminase (AST) within 2.5 times the upper limit of normal bilirubin <3 mg/dL 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	No
Contacts ^††
Location Countries ^†	United States, Belgium, Canada, France, Germany, Hungary, Italy, Poland, Russian Federation, Spain, United Kingdom

Administrative Information Fields
NCT ID ^†	NCT00090025
Organization ID	XL119-001
Secondary IDs ^††
Study Sponsor ^†	Helsinn Healthcare SA
Collaborators ^††
Investigators ^†
Information Provided By	Helsinn Healthcare SA
Verification Date	January 2007
First Received Date ^†	August 19, 2004
Last Updated Date	January 2, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.