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

Purpose

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

Genetics Home Reference related topics:

bladder cancer

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil BMS 181176

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	September 2004
Estimated Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090025

Show 59 Study Locations

Sponsors and Collaborators

Helsinn Healthcare SA

More Information

Study ID Numbers:	XL119-001
First Received:	August 19, 2004
Last Updated:	January 2, 2007
ClinicalTrials.gov Identifier:	NCT00090025
Health Authority:	United States: Food and Drug Administration

Keywords provided by Helsinn Healthcare SA:

Advanced Biliary Cancer

Cholangiocarcinoma

Gall bladder tumor

Gall bladder cancer

Bile duct tumor

Tumor of biliary tree

Study placed in the following topic categories:

Cholangiocarcinoma

Biliary Tract Neoplasms

Digestive System Neoplasms

Urinary Bladder Neoplasms

Biliary tract cancer

Leucovorin

Gall bladder cancer

Digestive System Diseases

Fluorouracil

Biliary Tract Diseases

Gastrointestinal Neoplasms

Gallbladder Neoplasms

Bile Duct Neoplasms

Bladder neoplasm

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Vitamin B Complex

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Vitamins

Micronutrients

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Helsinn Healthcare SA
Information provided by:	Helsinn Healthcare SA
ClinicalTrials.gov Identifier:	NCT00090025