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

NCT00090025 | Terminated Phase 3 DMC

• 1 other identifier: XL119-001
• Study Type: interventional
• Target: 248
• Locations: 11 countries
• Sites: 59

Brief 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.

Conditions

Biliary Tract Cancer

Keywords

Advanced Biliary Cancer; Cholangiocarcinoma; Gall bladder tumor; Gall bladder cancer; Bile duct tumor; Tumor of biliary tree

Outcome Measures

Primary Outcomes (1)

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

  time to death

Secondary Outcomes (1)

• 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

Study Arms (2)

becatecarin

EXPERIMENTAL

becatecarin

Drug: becatecarin

5-FU Plus Leucovorin (LV)

ACTIVE COMPARATOR

5-Fluorouracil (5-FU) Plus Leucovorin (LV)

Drug: 5-Fluorouracil Plus Leucovorin

Interventions

becatecarin DRUG

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

Also known as: XL119

becatecarin

5-Fluorouracil Plus Leucovorin DRUG

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

5-FU Plus Leucovorin (LV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinn Healthcare SA: lead

Study Sites (59)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Long Beach VA Medical Center

Long Beach, California, 90822, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

Pacific Hematology Oncology Associates

San Francisco, California, 94115, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Winship Cancer Institute, Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Carle Clinic Association

Urbana, Illinois, 61801, United States

Location

Medical Consultants, PC c/o Ball Cancer Center

Muncie, Indiana, 47303, United States

Location

Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Louisiana Oncology Associates

Lafayette, Louisiana, 70506, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Oncology Care Center PLLC

Saint Joseph, Michigan, 49085, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Cancer Treatment and Research Center

Bismarck, North Dakota, 58501, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Charleston Hematology Oncology, PA

Charleston, South Carolina, 29403, United States

Location

The Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Western Washington Oncology, Inc.

Lacey, Washington, 98503, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Location

Centre Hospitalier Universite de Montreal

Montreal, Quebec, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

CHU - Hospital Jean Minjoz

Besançon, 25030, France

Location

Hospital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

Centre Oscar Lambret

Lille, BP 307 - 59020, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Charite Berlin der Humbold Universitat

Berlin, D-13353, Germany

Location

Heinrich-Heine-Universitat-Dusseldorf

Düsseldorf, D-40225, Germany

Location

Allgem. Krankenhaus St. Georg

Hamburg, D-20099, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Universitätsklinikum Johannes Gutenberg

Mainz, D-55131, Germany

Location

Technischen Universitat Munchen

Munich, 81675, Germany

Location

Klinikum Grosshadern der Ludwig Maximilians Universitaet

Munich, Germany

Location

Universitätsklinikum Tübingen

Tübingen, D-72076, Germany

Location

Universitatsklinikum Ulm

Ulm, D-89081, Germany

Location

Orszagos Onkologiai Intezet

Budapest, Hungary

Location

Centro di Riferimento Oncologico di Aviano

Aviano, Italy

Location

Ospidale Civile di Livorno

Livorno, 57128, Italy

Location

Policlinico Universitario di Udine

Udine, 33100, Italy

Location

Centrum Onkologii - Instytut im. Marii

Warsaw, 02-781, Poland

Location

Cancer Research Center named after N.N. Blokhin, RAMS

Moscow, 115478, Russia

Location

Hospital Clinic i Provincial (Oncology Department)

Barcelona, 08036, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, Spain

Location

Hospital Provincial de Pontevedra

Pontevedra, Spain

Location

Hospital Lozano Blesa

Zaragoza, 50009, Spain

Location

Leicester Royal Infirmary

Leicester, England, United Kingdom

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms; Bile Duct Neoplasms

Interventions

becatecarin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Gallbladder Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Afshin Dowlati, MD

  Case Western Reserve University - Cleveland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 19, 2004
• First Posted: August 23, 2004
• Study Start: September 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 14, 2009

Record last verified: 2009-01

Locations

FR (4); US (27); DE (9); GB (1); HU (1); CA (5); ES (6); BE (1); PL (1); RU (1); IT (3)