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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Locally Advanced or Metastatic Adenoca of the Biliary Tract

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Trial Information

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


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;

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

OSI-904-202

NCT ID:

NCT00088270

Start Date:

August 2004

Completion Date:

August 2005

Related Keywords:

  • Locally Advanced or Metastatic Adenoca of the Biliary Tract
  • Biliary Tract Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Wayne State UniversityDetroit, Michigan  48202
Sidney Kimmel Comprehensive Cancer CenterLutherville, Maryland  
Robert H. Lurie Comp. Cancer Ctr of Northwestern UniversityChicago, Illinois  60611
Division of Hematology/OncologyColumbus, Ohio  43210