The purpose of this multi-center, randomized Phase II study is to evaluate the efficacy and safety of OSI-7904L versus 5 FU/LV in biliary tract cancer.

Condition	Treatment or Intervention	Phase
Bilary Tract Cancer	Drug: OSI-7904L  Drug: 5-Fluorouracil/Leucovorin	Phase II

Further Study Details: 

Expected Total Enrollment:  58

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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;

OSIP Medical Information      (800) 572-1932    medical-information@osip.com

Maryland
      The Johns Hopkins University, Baltimore,  Maryland,  21231,  United States; Not yet recruiting
Michigan
      Wayne State University, Detroit,  Michigan,  48201,  United States; Not yet recruiting
      University of Michigan, Ann Arbor,  Michigan,  48109,  United States; Not yet recruiting
Ohio
      Division of Hematology/Oncology, Columbus,  Ohio,  43210,  United States; Not yet recruiting
Tennessee
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232,  United States; Not yet recruiting
Belgium
      Institute Jules Bordet, Brussels,  1000,  Belgium; Not yet recruiting
      Dept Internal Medicine Gastrointestinal Oncology Unit, B-3000 Leuven,  Belgium; Not yet recruiting
      Department of Gastroenterology and GI Oncology, Brussels,  1070,  Belgium; Not yet recruiting
Germany
      Allgemeines Krankenhaus St. Georg, Hamburg,  20099,  Germany; Not yet recruiting
      Medizinische Klinik IILMU-Klinikum-Großhadern, München,  81377,  Germany; Not yet recruiting
      Universitätsklinikum Charite Campus Virchow, Berlin,  13353,  Germany; Not yet recruiting
      Tumorforschung Innere Medizinische Klinik, ESSEN,  45122,  Germany; Not yet recruiting
      Innere MedizinUniversitatsklinikum Heidelberg, Heidelberg,  69115,  Germany; Not yet recruiting
      Klinikum der J. W. Groethe-Universitat, Frankfurt,  60590,  Germany; Not yet recruiting
Poland
      Klinika Chemioterapii, Krakow,  31-115,  Poland; Not yet recruiting
      Klinika Nowotworow Gornego Odcinka, Warszawa,  02-791,  Poland; Not yet recruiting
Romania
      Oncology Institute Ion Chiricuta, Cluj Napoca,  3400,  Romania; Recruiting
      Institutul Clinic Fundeni, Bucuresti,  72437,  Romania; Not yet recruiting
Switzerland
      OncosurgeryUniversity Hospital of Geneva, Geneva,  1211,  Switzerland; Not yet recruiting
      Multidisciplinary Oncology Center University Hospital CHUV, Lausanne,  1011,  Switzerland; Not yet recruiting

Study ID Numbers:  OSI-904-202
Record last reviewed:  December 2004
Last Updated:  December 10, 2004
Record first received:  July 23, 2004
ClinicalTrials.gov Identifier:  NCT00088270
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08