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

Sponsor
Helsinn Healthcare SA (Industry)
Overall Status
Terminated
CT.gov ID
NCT00090025
Collaborator
(none)
248
Enrollment
59
Locations
2
Arms
26
Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
248 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Nov 1, 2006
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: becatecarin

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
Other Names:
  • XL119

    		•
    Active Comparator: 5-FU Plus Leucovorin (LV)

    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

    Outcome Measures

    Primary Outcome Measures

    1. To compare survival duration for XL119 and 5-FU/LV treated subjects [time to death]

    Secondary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 Long Beach VA Medical Center Long Beach California United States 90822
    3 University of California, Irvine Medical Center Orange California United States 92868
    4 Sharp Clinical Oncology Research San Diego California United States 92123
    5 Pacific Hematology Oncology Associates San Francisco California United States 94115
    6 Yale University School of Medicine New Haven Connecticut United States 06520
    7 Tampa General Hospital Tampa, Florida United States 33606
    8 Winship Cancer Institute, Emory University Hospital Atlanta Georgia United States 30322
    9 Carle Clinic Association Urbana Illinois United States 61801
    10 Medical Consultants, PC c/o Ball Cancer Center Muncie Indiana United States 47303
    11 Oncology Associates Cedar Rapids Iowa United States 52403
    12 Louisiana Oncology Associates Lafayette Louisiana United States 70506
    13 Tufts - New England Medical Center Boston Massachusetts United States 02111
    14 Josephine Ford Cancer Center at Henry Ford Health System Detroit Michigan United States 48202
    15 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    16 Oncology Care Center PLLC St. Joseph Michigan United States 49085
    17 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756
    18 Queens Hospital Center Jamaica New York United States 11432
    19 SUNY Upstate Medical University Syracuse New York United States 13210
    20 New York Medical College Valhalla New York United States 10595
    21 Cancer Treatment and Research Center Bismark North Dakota United States 58501
    22 Gabrail Cancer Center Canton Ohio United States 44718
    23 Case Western Reserve University Cleveland Ohio United States 44106
    24 Charleston Hematology Oncology, PA Charleston South Carolina United States 29403
    25 The Sarah Cannon Cancer Center Nashville Tennessee United States 37203
    26 Western Washington Oncology, Inc. Lacey Washington United States 98503
    27 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792
    28 Universitair Ziekenhuis Gent Ghent Belgium
    29 British Columbia Cancer Agency - Vancouver Centre Vancouver British Columbia Canada V5Z 4E6
    30 London Regional Cancer Centre London Ontario Canada N6A 4L6
    31 Ottawa Regional Cancer Centre Ottawa Ontario Canada
    32 Centre Hospitalier Universite de Montreal Montreal Quebec Canada
    33 Jewish General Hospital Montreal Quebec Canada
    34 CHU - Hospital Jean Minjoz Besancon cedex France 25030
    35 Hospital Ambroise Pare Boulogne Billancourt France 92100
    36 Centre Oscar Lambret Lille cedex France BP 307 - 59020
    37 Institut Gustave Roussy Villejuif Cedex France 94805
    38 Charite Berlin der Humbold Universitat Berlin Germany D-13353
    39 Heinrich-Heine-Universitat-Dusseldorf Dusseldorf Germany D-40225
    40 Allgem. Krankenhaus St. Georg Hamburg Germany D-20099
    41 Medizinische Hochschule Hannover Hannover Germany D-30625
    42 Universitätsklinikum Johannes Gutenberg Mainz Germany D-55131
    43 Technischen Universitat Munchen Munich Germany 81675
    44 Klinikum Grosshadern der Ludwig Maximilians Universitaet Munich Germany
    45 Universitätsklinikum Tübingen Tübingen Germany D-72076
    46 Universitatsklinikum Ulm Ulm Germany D-89081
    47 Orszagos Onkologiai Intezet Budapest Hungary
    48 Centro di Riferimento Oncologico di Aviano Aviano Italy
    49 Ospidale Civile di Livorno Livorno Italy 57128
    50 Policlinico Universitario di Udine Udine Italy 33100
    51 Centrum Onkologii - Instytut im. Marii Warszawa Poland 02-781
    52 Cancer Research Center named after N.N. Blokhin, RAMS Moscow Russian Federation 115478
    53 Hospital Clinic i Provincial (Oncology Department) Barcelona Spain 08036
    54 Hospital Clínico San Carlos Madrid Spain 28040
    55 Hospital 12 de Octubre Madrid Spain 28041
    56 Hospital Regional Universitario Carlos Haya Malaga Spain
    57 Hospital Provincial de Pontevedra Pontevedra Spain
    58 Hospital Lozano Blesa Zaragoza Spain 50009
    59 Leicester Royal Infirmary Leicester England United Kingdom

    Sponsors and Collaborators

    • Helsinn Healthcare SA

    Investigators

    • Study Chair: Afshin Dowlati, MD, Case Western Reserve University - Cleveland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00090025
    Other Study ID Numbers:
    • XL119-001
    First Posted:
    Aug 23, 2004
    Last Update Posted:
    Jan 14, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    Advanced Biliary Cancer
    Cholangiocarcinoma
    Gall bladder tumor
    Gall bladder cancer
    Bile duct tumor
    Tumor of biliary tree
    Additional relevant MeSH terms:
    Biliary Tract Neoplasms
    Leucovorin
    Fluorouracil

    Study Results

    No Results Posted as of Jan 14, 2009