Locally Advanced or Metastatic Adenoca of the Biliary Tract Clinical Trial
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
| Verified date | May 2004 |
| Source | OSI Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Multi-center, randomized Phase II study to evaluate the efficacy and safety of OSI-7904Lversus 5 FU/LV in biliary tract cancer.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | August 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Institute Jules Bordet | 1000 Brussels | |
| Belgium | Dept Internal Medicine Gastrointestinal Oncology Unit | B-3000 Leuven | |
| Belgium | Department of Gastroenterology and GI Oncology | Brussels 1070 | |
| Germany | 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 | |
| Poland | Klinika Nowotworow Gornego Odcinka | 02-791 Warszawa | |
| Poland | Klinika Chemioterapii | 31-115 Krakow | |
| Romania | Institutul Clinic Fundeni | 72437 Bucuresti | |
| Romania | Oncology Institute Ion Chiricuta | Cluj Napoca | |
| Switzerland | Oncosurgery University Hospital of Geneva | 1211 Geneva 14 | |
| Switzerland | Multidisciplinary Oncology Center University Hospital CHUV | Lausanne | |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
| United States | Robert H. Lurie Comp. Cancer Ctr of Northwestern University | Chicago | Illinois |
| United States | Division of Hematology/Oncology | Columbus | Ohio |
| United States | Wayne State University | Detroit | Michigan |
| United States | Vanderbilt Cancer Center | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| OSI Pharmaceuticals |
United States, Belgium, Germany, Poland, Romania, Switzerland,