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

February 17, 2006 updated by: OSI Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSI Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

July 23, 2004

First Submitted That Met QC Criteria

July 23, 2004

First Posted (Estimate)

July 26, 2004

Study Record Updates

Last Update Posted (Estimate)

February 22, 2006

Last Update Submitted That Met QC Criteria

February 17, 2006

Last Verified

May 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI-904-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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