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	Treatment or Intervention	Phase
Biliary Tract Cancer	Drug: XL119  Drug: 5-Fluorouracil and Leucovorin	Phase III

Primary Objective

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

Secondary Objectives

• 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
• To assess the safety profile of XL119

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Michelle LaBruyere      615 313 6859    michelle.labruyere@covance.com

Michigan
      Oncology Care Center PLLC, St. Joseph,  Michigan,  49085,  United States; Recruiting
New York
      Queens Hospital Center, Jamaica,  New York,  11432,  United States; Recruiting
Ohio
      Gabrail Cancer Center, Canton,  Ohio,  44718,  United States; Recruiting
South Carolina
      Charleston Hematology Oncology, PA, Charleston,  South Carolina,  29403,  United States; Recruiting

Study chairs or principal investigators

Harold Keer, M.D., Ph.D.,  Study Director,  Exelixis, Inc.   

Study ID Numbers:  XL119-001
Record last reviewed:  August 2004
Record first received:  August 19, 2004
ClinicalTrials.gov Identifier:  NCT00090025
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10