A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00088270
Recruitment Status : Completed
First Posted : July 26, 2004
Last Update Posted : February 22, 2006
Information provided by:
OSI Pharmaceuticals

Brief Summary:
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Adenoca of the Biliary Tract Drug: OSI-7904L Drug: 5-Fluorouracil/Leucovorin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Phase II Study of OSI-7904L Versus 5-FU/LV as First-Line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Adenocarcinoma of the Biliary Tract
Study Start Date : August 2004
Study Completion Date : August 2005

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Documented locally advanced or metastatic adenocarcinoma of the biliary tract; Adequate bone marrow, hepatic and renal function; Bilirubin <= 1.5 times the upper limit of normal; Age 18 years or older; Predicted life expectancy 12 weeks or more; Prior surgery and radiation therapy permitted provided patient has recovered adequately; At least 1 target lesion >= 20 mm (or >= 10 mm on spiral CT-scan); ECOG Performance Status 0-2; No prior chemotherapy for locally advanced or metastatic disease. Adjuvant/neo-adjuvant permitted if therapy was completed at least 12 months prior to study entry;

Exclusion Criteria:

Concurrent anticancer therapy while on study; History of other malignancy within the past 3 years except basal or squamous cell carcinoma or in situ cervical cancer; Symptomatic brain metastases which are not stable or have required radiation in the past 28 days;

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00088270

United States, Illinois
Robert H. Lurie Comp. Cancer Ctr of Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States, 48201
United States, Ohio
Division of Hematology/Oncology
Columbus, Ohio, United States, 43210
United States, Tennessee
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232
Institute Jules Bordet
1000 Brussels, Belgium
Dept Internal Medicine Gastrointestinal Oncology Unit
B-3000 Leuven, Belgium
Department of Gastroenterology and GI Oncology
Brussels 1070, Belgium
Universitätsklinikum Charite Campus Virchow
13353 Berlin, Germany
Allgemeines Krankenhaus St. Georg
20099 Hamburg, Germany
Klinikum der J. W. Groethe-Universitat
60590 Frankfurt, Germany
Innere Medizin Universitatsklinikum Heidelberg
69115 Heidelberg, Germany
Medizinische Klinik II LMU-Klinikum-Großhadern
81377 München, Germany
Tumorforschung Innere Medizinische Klinik
Essen, Germany, 45122
Klinika Nowotworow Gornego Odcinka
02-791 Warszawa, Poland
Klinika Chemioterapii
31-115 Krakow, Poland
Institutul Clinic Fundeni
72437 Bucuresti, Romania
Oncology Institute Ion Chiricuta
Cluj Napoca, Romania, 3400
Oncosurgery University Hospital of Geneva
1211 Geneva 14, Switzerland
Multidisciplinary Oncology Center University Hospital CHUV
Lausanne, Switzerland, 1011
Sponsors and Collaborators
OSI Pharmaceuticals Identifier: NCT00088270     History of Changes
Other Study ID Numbers: OSI-904-202
First Posted: July 26, 2004    Key Record Dates
Last Update Posted: February 22, 2006
Last Verified: May 2004

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs