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

NCT ID: NCT00088270

Last Updated: 2006-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-08-31

Brief Summary

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

Detailed Description

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Conditions

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Locally Advanced or Metastatic Adenoca of the Biliary Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OSI-7904L

Intervention Type DRUG

5-Fluorouracil/Leucovorin

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OSI Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Robert H. Lurie Comp. Cancer Ctr of Northwestern University

Chicago, Illinois, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Division of Hematology/Oncology

Columbus, Ohio, United States

Site Status

Vanderbilt Cancer Center

Nashville, Tennessee, United States

Site Status

Institute Jules Bordet

1000 Brussels, , Belgium

Site Status

Dept Internal Medicine Gastrointestinal Oncology Unit

B-3000 Leuven, , Belgium

Site Status

Department of Gastroenterology and GI Oncology

Brussels, , Belgium

Site Status

Universitätsklinikum Charite Campus Virchow

13353 Berlin, , Germany

Site Status

Allgemeines Krankenhaus St. Georg

20099 Hamburg, , Germany

Site Status

Klinikum der J. W. Groethe-Universitat

60590 Frankfurt, , Germany

Site Status

Innere Medizin Universitatsklinikum Heidelberg

69115 Heidelberg, , Germany

Site Status

Medizinische Klinik II LMU-Klinikum-Großhadern

81377 München, , Germany

Site Status

Tumorforschung Innere Medizinische Klinik

Essen, , Germany

Site Status

Klinika Nowotworow Gornego Odcinka

02-791 Warszawa, , Poland

Site Status

Klinika Chemioterapii

31-115 Krakow, , Poland

Site Status

Institutul Clinic Fundeni

72437 Bucuresti, , Romania

Site Status

Oncology Institute Ion Chiricuta

Cluj-Napoca, , Romania

Site Status

Oncosurgery University Hospital of Geneva

1211 Geneva 14, , Switzerland

Site Status

Multidisciplinary Oncology Center University Hospital CHUV

Lausanne, , Switzerland

Site Status

Countries

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United States Belgium Germany Poland Romania Switzerland

Other Identifiers

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OSI-904-202

Identifier Type: -

Identifier Source: org_study_id