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

This study has been completed.
Information provided by:
OSI Pharmaceuticals Identifier:
First received: July 23, 2004
Last updated: February 17, 2006
Last verified: May 2004
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment: 58
Study Start Date: August 2004
Estimated Study Completion Date: August 2005

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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Please refer to this study by its identifier: 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
  More Information Identifier: NCT00088270     History of Changes
Other Study ID Numbers: OSI-904-202
Study First Received: July 23, 2004
Last Updated: February 17, 2006

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017