A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer
Completed · Phase 2
Conditions studied: Locally Advanced or Metastatic Adenoca of the Biliary Tract
In brief
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.
Key facts
- Study ID
- NCT00088270
- Run by
- OSI Pharmaceuticals
- People needed
- 58
- Starts
- 2004-08-01
- Expected to finish
- 2005-08-01
- Last updated by the study team
- 2006-02-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
Where it is running
- Robert H. Lurie Comp. Cancer Ctr of Northwestern University — Chicago, Illinois, United States
- Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Wayne State University — Detroit, Michigan, United States
- Division of Hematology/Oncology — Columbus, Ohio, United States
- Vanderbilt Cancer Center — Nashville, Tennessee, United States
- Institute Jules Bordet — 1000 Brussels, Belgium
- Dept Internal Medicine Gastrointestinal Oncology Unit — B-3000 Leuven, Belgium
- Department of Gastroenterology and GI Oncology — Brussels, 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
- 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
- Oncosurgery University Hospital of Geneva — 1211 Geneva 14, Switzerland
- Multidisciplinary Oncology Center University Hospital CHUV — Lausanne, Switzerland
Full record on ClinicalTrials.gov
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