Clinical trial NCT00088270: A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced or Metastatic Adenoca of the Biliary Tract
Lead sponsor: OSI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-07-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comp. Cancer Ctr of Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Columbus
country: United States
facility: Division of Hematology/Oncology
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Cancer Center
state: Tennessee
city: 1000 Brussels
country: Belgium
facility: Institute Jules Bordet
city: B-3000 Leuven
country: Belgium
facility: Dept Internal Medicine Gastrointestinal Oncology Unit
city: Brussels 1070
country: Belgium
facility: Department of Gastroenterology and GI Oncology
city: 13353 Berlin
country: Germany
facility: Universitätsklinikum Charite Campus Virchow
city: 20099 Hamburg
country: Germany
facility: Allgemeines Krankenhaus St. Georg
city: 60590 Frankfurt
country: Germany
facility: Klinikum der J. W. Groethe-Universitat
city: 69115 Heidelberg
country: Germany
facility: Innere Medizin Universitatsklinikum Heidelberg
city: 81377 München
country: Germany
facility: Medizinische Klinik II LMU-Klinikum-Großhadern
city: Essen
country: Germany
facility: Tumorforschung Innere Medizinische Klinik
city: 02-791 Warszawa
country: Poland
facility: Klinika Nowotworow Gornego Odcinka
city: 31-115 Krakow
country: Poland
facility: Klinika Chemioterapii
city: 72437 Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Cluj Napoca
country: Romania
facility: Oncology Institute Ion Chiricuta
city: 1211 Geneva 14
country: Switzerland
facility: Oncosurgery University Hospital of Geneva
city: Lausanne
country: Switzerland
facility: Multidisciplinary Oncology Center University Hospital CHUV
Study officials:
References: