Safety and Efficacy Therapy of Gemcitabine and Erbitux® to R0 or R1 Resected Pancreatic Cancer

Summary

This is an open-label, non-randomized Phase II study to evaluate immunochemotherapy in patients with R0 OR R1-resected pancreatic cancer.

Timeline

Start

2006-10

Primary completion

2010-11

Completion

2012-01

Outcome

Missed primary endpoint

paper DFS rate at month 18 of 27.1% (16.7%-37.6%) was inferior to 35%. PMID 23897705 ↗

Publications

• Results Fensterer H, Schade-Brittinger C, Muller HH, Tebbe S, Fass J, Lindig U, Settmacher U, Schmidt WE, Marten A, Ebert MP, Kornmann M, Hofheinz R, Endlicher E, Brendel C, Barth PJ, Bartsch DK, Michl P, Gress TM; Arbeitsgemeinschaft Internistische Onkologie (AIO). Multicenter phase II trial to investigate safety and efficacy of gemcitabine combined with cetuximab as adjuvant therapy in pancreatic cancer (ATIP). Ann Oncol. 2013 Oct;24(10):2576-2581. doi: 10.1093/annonc/mdt270. Epub 2013 Jul 29.

Drugs

Indications