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

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

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: becatecarin Drug: 5-Fluorouracil Plus Leucovorin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor BMS 181176 Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:

To compare survival duration for XL119 and 5-FU/LV treated subjects [ Time Frame: time to death ] [ Designated as safety issue: No ]

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 [ Time Frame: time to progressive disease ] [ Designated as safety issue: No ]

Enrollment:	248
Study Start Date:	September 2004
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
becatecarin: Experimental becatecarin	Drug: becatecarin 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
5-FU Plus Leucovorin (LV): Active Comparator 5-Fluorouracil (5-FU) Plus Leucovorin (LV)	Drug: 5-Fluorouracil Plus Leucovorin 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

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

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

Investigators

Study Chair:

Afshin Dowlati, MD

Case Western Reserve University - Cleveland

More Information

No publications provided

Responsible Party:	Pharma Company Sponsor ( Helsinn Healthcare SA )
Study ID Numbers:	XL119-001
Study First Received:	August 19, 2004
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00090025 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Canada: Health Canada; Canada: Ethics Review Committee; Germany: Ministry of Health; Germany: Ethics Commission; Hungary: National Institute of Pharmacy; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Russia: Ethics Committee; Spain: Ministry of Health; Spain: Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Helsinn Healthcare SA:

Advanced Biliary Cancer
Cholangiocarcinoma
Gall bladder tumor

Gall bladder cancer
Bile duct tumor
Tumor of biliary tree

Additional relevant MeSH terms:

Antimetabolites
Vitamin B Complex
Biliary Tract Neoplasms
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Leucovorin

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Vitamins
Therapeutic Uses
Biliary Tract Diseases
Fluorouracil
Micronutrients

ClinicalTrials.gov processed this record on November 27, 2009