NCT00552149

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Biliary Cancer

Interventions

Type	Name	Description
DRUG	Gemox, Cetuximab	GEMOX (Arms 1 and 2), every two weeks: Day 1: gemcitabine 1000 mg/m² intravenous (IV) infusion over 100 minutes (10 mg/m²/min) Day 2: oxaliplatin 100 mg/m² IV infusion over 2 h Cetuximab (ErbituxÒ) (Arm B only) every two weeks: (chemotherapy will be started one hour after the end of the cetuximab infusion). Day 1 or Day 2: 500 mg/m² IV infusion over 150 minutes

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2007-11-01
• Last updated: 2012-06-13

Locations

1 site across 1 country: France