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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

Phase 3
18 Years
Not Enrolling
Biliary Tract Cancer

Thank you

Trial Information

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

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

- Pregnant or breast-feeding

- A known history of human immunodeficiency virus (HIV) infection

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

time to death

Safety Issue:


Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Western Reserve University - Cleveland


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

November 2006

Related Keywords:

  • Biliary Tract Cancer
  • Advanced Biliary Cancer
  • Cholangiocarcinoma
  • Gall bladder tumor
  • Gall bladder cancer
  • Bile duct tumor
  • Tumor of biliary tree
  • Biliary Tract Neoplasms



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Norris Cotton Cancer CenterLebanon, New Hampshire  03756
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
New York Medical CollegeValhalla, New York  10595
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Tufts - New England Medical CenterBoston, Massachusetts  02111
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Louisiana Oncology AssociatesLafayette, Louisiana  70506
SUNY Upstate Medical UniversitySyracuse, New York  13210
Queens Hospital CenterJamaica, New York  11432
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Oncology AssociatesCedar Rapids, Iowa  52403
Yale University School Of MedicineNew Haven, Connecticut  06520
Sharp Clinical Oncology ResearchSan Diego, California  92123
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Winship Cancer Institute, Emory University HospitalAtlanta, Georgia  30322
Medical Consultants, PC c/o Ball Cancer CenterMuncie, Indiana  47303
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