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

Phase 2

Completed

• Conditions: Locally Advanced or Metastatic Adenoca of the Biliary Tract

• Registration Number: NCT00088270
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2004-05
• Study First Submitted: 2004-07-23
• Study First Submitted QC: 2004-07-23
• Study First Posted: 2004-07-26
• Study Start: 2004-08
• Study Completion: 2005-08
• Last Update Submitted: 2006-02-17
• Last Update Posted: 2006-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (21)

Department of Gastroenterology and GI Oncology; 🇧🇪 Brussels 1070, Belgium

Medizinische Klinik II LMU-Klinikum-Großhadern; 🇩🇪 81377 München, Germany

Tumorforschung Innere Medizinische Klinik; 🇩🇪 Essen, Germany

Oncology Institute Ion Chiricuta; 🇷🇴 Cluj Napoca, Romania

Klinika Nowotworow Gornego Odcinka; 🇵🇱 02-791 Warszawa, Poland

Allgemeines Krankenhaus St. Georg; 🇩🇪 20099 Hamburg, Germany

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Institutul Clinic Fundeni; 🇷🇴 72437 Bucuresti, Romania

Klinikum der J. W. Groethe-Universitat; 🇩🇪 60590 Frankfurt, Germany

Innere Medizin Universitatsklinikum Heidelberg; 🇩🇪 69115 Heidelberg, Germany

Division of Hematology/Oncology; 🇺🇸 Columbus, Ohio, United States

Universitätsklinikum Charite Campus Virchow; 🇩🇪 13353 Berlin, Germany

Klinika Chemioterapii; 🇵🇱 31-115 Krakow, Poland

Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Oncosurgery University Hospital of Geneva; 🇨🇭 1211 Geneva 14, Switzerland

Institute Jules Bordet; 🇧🇪 1000 Brussels, Belgium

Dept Internal Medicine Gastrointestinal Oncology Unit; 🇧🇪 B-3000 Leuven, Belgium

Robert H. Lurie Comp. Cancer Ctr of Northwestern University; 🇺🇸 Chicago, Illinois, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Multidisciplinary Oncology Center University Hospital CHUV; 🇨🇭 Lausanne, Switzerland