Status:
COMPLETED
A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer
Lead Sponsor:
OSI Pharmaceuticals
Conditions:
Locally Advanced or Metastatic Adenoca of the Biliary Tract
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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;
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00088270
Start Date
August 1 2004
End Date
August 1 2005
Last Update
February 22 2006
Active Locations (21)
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1
Robert H. Lurie Comp. Cancer Ctr of Northwestern University
Chicago, Illinois, United States, 60611
2
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Wayne State University
Detroit, Michigan, United States, 48201