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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00090025
• Date of registration: 19/08/2004
• Prospective Registration: Yes
• Primary sponsor: Helsinn Healthcare SA
• Public title: XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
• Scientific 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
• Date of first enrolment: September 2004
• Target sample size: 248
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00090025
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, France, Germany, Hungary, Italy, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Afshin Dowlati, MD
• Affiliation: Case Western Reserve University - Cleveland

Key inclusion & exclusion 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Biliary Tract Cancer

Intervention(s)

Drug: 5-Fluorouracil Plus Leucovorin

Drug: becatecarin

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

XL119-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors