A Study of OSI-7904L Versus 5-FU/LV as Treatment in Patients With Biliary Tract Cancer

OSI Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Locally Advanced or Metastatic Adenoca of the Biliary Tract

Treatments

Drug: OSI-7904L

Drug: 5-Fluorouracil/Leucovorin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00088270

OSI-904-202

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;