Biliary Cancers: EGFR INhibitor, Gemcitabine and Oxaliplatin
A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.
The BINGO trial is an open-label randomized phase II study evaluating the efficacy and tolerance of gemcitabine-oxaliplatin combination chemotherapy (GEMOX regimen) alone or in combination with cetuximab in patients (pts) with ABC. The BINGO study also comprises ancillary translational research and functional imaging studies which aim to identify markers predictive for treatment efficacy in ABC.
All eligible pts will be randomized 1:1 to receive:
- Arm A: GEMOX alone every two weeks.
- Arm B: GEMOX + cetuximab every two weeks.
Randomization will be stratified according to:
1. tumor stage (locally advanced vs metastatic),
2. primary tumor location (gallbladder vs non-gallbladder),
3. prior treatments (surgery or radiotherapy or brachytherapy or photodynamic therapy [PDT] or adjuvant chemotherapy vs none),
4. center. EGFR tumor status has to be assessed for every pt by immunohistochemistry (IHC) using biopsy or surgical material, at any time prior to inclusion into the study, but it is neither an inclusion/exclusion criterion nor a stratification factor.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Advanced Biliary Cancer
Institut Gustave Roussy
Active, not recruiting
Institut Gustave Roussy
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00552149
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Biliary Tract Neoplasms
Tumors or cancer in the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.
Abnormal passage in any organ of the biliary tract or between biliary organs and other organs.
Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.
An antineoplastic agent that is a derivative of progesterone and used to treat advanced breast cancer.
Infection of the biliary passages with CLONORCHIS SINENSIS, also called Opisthorchis sinensis. It may lead to inflammation of the biliary tract, proliferation of biliary epithelium, progressive portal fibrosis, and sometimes bile duct carcinoma. Extension to the liver may lead to fatty changes and cirrhosis. (From Dorland, 27th ed)
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