Conditions: Extrahepatic Bile Duct Cancer Gallbladder Cancer
Keywords: GALL BLADDER BILE DUCTS BAY 43-9006 SORAFENIB CISPLATIN GEMCITABINE 09-029
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers.

Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. We are looking to improve treatment results. We will attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan. Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the cancer cells grow and divide. This study will help answer the question of whether sorafenib is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.

This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile duct and gallbladder cancers.

Detailed description:

Arms:
arm 1: This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.

Interventions: intervention 1: Gemcitabine intervention 2: Cisplatin intervention 3: Sorafenib
Intervention descriptions: intervention 1: Gemcitabine: 800 mg/m\^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment. intervention 2: 20 mg /m\^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment. intervention 3: 400 mg PO once a day continuously.

Protocol document: