drugset / Trial / NCT00852228
Optimal Control of Liver Metastases From Colorectal Cancer With Cetuximab and Hepatic Artery Infusion of Chemotherapy
Phase 2
Unknown
60 enrolled
Association pour la Recherche sur le Temps Biologique et la Chronothérapie
CRESGE · collabGustave Roussy, Cancer Campus, Grand Paris · collabMerck Serono International SA · collabPfizer · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to increase by 15% the complete macroscopic resection rate of predominantly liver metastases from metastatic colorectal cancer through combining systemic cetuximab and hepatic artery infusion of three-drug chemotherapy (irinotecan, oxaliplatin and 5-fluorouracil).
Timeline
- Start
- 2008-07
- Primary completion
- 2012-03
- Completion
- 2015-12
Outcome
Met primary endpoint
paper The primary end point was met, with R0-R1 hepatectomy for 19 of the 64 previously treated patients, 29.7% PMID 26578731 ↗
Publications
- Bouchahda M, Boige V, Smith D, Karaboue A, Ducreux M, Hebbar M, Lepere C, Focan C, Guimbaud R, Innominato P, Awad S, Carvalho C, Tumolo S, Truant S, De Baere T, Castaing D, Rougier P, Morere JF, Taieb J, Adam R, Levi F; ARTBC International. Early tumour response as a survival predictor in previously- treated patients receiving triplet hepatic artery infusion and intravenous cetuximab for unresectable liver metastases from wild-type KRAS colorectal cancer. Eur J Cancer. 2016 Nov;68:163-172. doi: 10.1016/j.ejca.2016.09.011. Epub 2016 Oct 18.
- Levi FA, Boige V, Hebbar M, Smith D, Lepere C, Focan C, Karaboue A, Guimbaud R, Carvalho C, Tumolo S, Innominato P, Ajavon Y, Truant S, Castaing D, De Baere T, Kunstlinger F, Bouchahda M, Afshar M, Rougier P, Adam R, Ducreux M; Association Internationale pour Recherche sur Temps Biologique et Chronotherapie (ARTBC International). Conversion to resection of liver metastases from colorectal cancer with hepatic artery infusion of combined chemotherapy and systemic cetuximab in multicenter trial OPTILIV. Ann Oncol. 2016 Feb;27(2):267-74. doi: 10.1093/annonc/mdv548. Epub 2015 Nov 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Subject | fluorouracil | Small molecule | 2800 mg/m2 | Other |