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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Biliary Tract Cancer

Intervention / Treatment
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* Drug: becatecarin
* Drug: 5-Fluorouracil Plus Leucovorin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: becatecarin<br>becatecarin | Drug: becatecarin<br>* 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<br>* Other names: XL119;|
| Active Comparator: 5-FU Plus Leucovorin (LV)<br>5-Fluorouracil (5-FU) Plus Leucovorin (LV) | Drug: 5-Fluorouracil Plus Leucovorin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare survival duration for XL119 and 5-FU/LV treated subjects |  | time to death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 to progressive disease | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Biliary Cancer, Cholangiocarcinoma, Gall bladder tumor, Gall bladder cancer, Bile duct tumor, Tumor of biliary tree