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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.
Sponsor:
Information provided by:
OSI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00088270
First received: July 23, 2004
Last updated: February 17, 2006
Last verified: May 2004
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by OSI Pharmaceuticals:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088270

Locations
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
Belgium
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
Germany
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
Poland
Klinika Nowotworow Gornego Odcinka
02-791 Warszawa, Poland
Klinika Chemioterapii
31-115 Krakow, Poland
Romania
Institutul Clinic Fundeni
72437 Bucuresti, Romania
Oncology Institute Ion Chiricuta
Cluj Napoca, Romania, 3400
Switzerland
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

No publications provided

ClinicalTrials.gov Identifier: NCT00088270     History of Changes
Other Study ID Numbers: OSI-904-202
Study First Received: July 23, 2004
Last Updated: February 17, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Fluorouracil
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 18, 2013