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

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00090025
• Other study ID #: XL119-001
• Status: Terminated
• Phase: Phase 3
• First received: August 19, 2004
• Last updated: January 13, 2009
• Start date: September 2004
• Est. completion date: November 2006

Study information

• Verified date: January 2009
• Source: Helsinn Healthcare SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardCanada: Health CanadaCanada: Ethics Review CommitteeGermany: Ministry of HealthGermany: Ethics CommissionHungary: National Institute of PharmacyItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthPoland: Ministry of HealthRussia: Ministry of Health of the Russian FederationRussia: Ethics CommitteeSpain: Ministry of HealthSpain: Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 248
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

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-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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Ghent
Canada	London Regional Cancer Centre	London	Ontario
Canada	Centre Hospitalier Universite de Montreal	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia
France	CHU - Hospital Jean Minjoz	Besancon cedex
France	Hospital Ambroise Pare	Boulogne Billancourt
France	Centre Oscar Lambret	Lille cedex
France	Institut Gustave Roussy	Villejuif Cedex
Germany	Charite Berlin der Humbold Universitat	Berlin
Germany	Heinrich-Heine-Universitat-Dusseldorf	Dusseldorf
Germany	Allgem. Krankenhaus St. Georg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Johannes Gutenberg	Mainz
Germany	Klinikum Grosshadern der Ludwig Maximilians Universitaet	Munich
Germany	Technischen Universitat Munchen	Munich
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Universitatsklinikum Ulm	Ulm
Hungary	Orszagos Onkologiai Intezet	Budapest
Italy	Centro di Riferimento Oncologico di Aviano	Aviano
Italy	Ospidale Civile di Livorno	Livorno
Italy	Policlinico Universitario di Udine	Udine
Poland	Centrum Onkologii - Instytut im. Marii	Warszawa
Russian Federation	Cancer Research Center named after N.N. Blokhin, RAMS	Moscow
Spain	Hospital Clinic i Provincial (Oncology Department)	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Regional Universitario Carlos Haya	Malaga
Spain	Hospital Provincial de Pontevedra	Pontevedra
Spain	Hospital Lozano Blesa	Zaragoza
United Kingdom	Leicester Royal Infirmary	Leicester	England
United States	Winship Cancer Institute, Emory University Hospital	Atlanta	Georgia
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Cancer Treatment and Research Center	Bismark	North Dakota
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	Gabrail Cancer Center	Canton	Ohio
United States	Oncology Associates	Cedar Rapids	Iowa
United States	Charleston Hematology Oncology, PA	Charleston	South Carolina
United States	Case Western Reserve University	Cleveland	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Health System	Detroit	Michigan
United States	Queens Hospital Center	Jamaica	New York
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Western Washington Oncology, Inc.	Lacey	Washington
United States	Louisiana Oncology Associates	Lafayette	Louisiana
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Long Beach VA Medical Center	Long Beach	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Medical Consultants, PC c/o Ball Cancer Center	Muncie	Indiana
United States	The Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	University of California, Irvine Medical Center	Orange	California
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Pacific Hematology Oncology Associates	San Francisco	California
United States	Oncology Care Center PLLC	St. Joseph	Michigan
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Tampa General Hospital	Tampa,	Florida
United States	Carle Clinic Association	Urbana	Illinois
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Healthcare SA

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare survival duration for XL119 and 5-FU/LV treated subjects		time to death	No
Secondary	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	No