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Sponsors and Collaborators: |
Institut Gustave Roussy Merck Serono International SA |
Information provided by: | Institut Gustave Roussy |
ClinicalTrials.gov Identifier: | NCT00552149 |
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.
Condition | Intervention | Phase |
Advanced Biliary Cancer |
Drug: Gemox, Cetuximab |
Phase II |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Oxaliplatin Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 100 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2010 |
Arms | Assigned Interventions |
1: Active Comparator
GEMOX
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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 |
2: Experimental
GEMOX + CETUXIMAB
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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 |
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:
Randomization will be stratified according to:
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adenocarcinoma of the biliary tract (gallbladder, intra and/or extrahepatic bile ducts, or ampulla of Vater):
Exclusion Criteria:
Contact: David MALKA, MD | 33.1.42.11.50.42 | david.malka@igr.fr |
Contact: Jean-Pierre PIGNON, MD | 33.1.42.11.45.65. | jppignon@igr.fr |
France | |||||
Institut Gustave Roussy | Recruiting | ||||
VILLEJUIF, France, 94800 | |||||
Contact: David MALKA, MD 33.1.42.11.50.42. david.malka@igr.fr |
Institut Gustave Roussy |
Merck Serono International SA |
Study Chair: | David MALKA, MD | Institut Gustave Roussy |
Study ID Numbers: | BINGO, CSET 1287 |
First Received: | October 31, 2007 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00552149 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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