TY  - JOUR
A1  - Friess, Helmut
A1  - Langrehr, Jan M.
A1  - Oettle, Helmut
A1  - Raedle, Jochen
A1  - Niedergethmann, Marco
A1  - Dittrich, Christian
A1  - Hossfeld, Dieter K.
A1  - Stöger, Herbert
A1  - Neyns, Bart
A1  - Herzog, Peter
A1  - Piedbois, Pascal
A1  - Dobrowolski, Frank
A1  - Scheithauer, Werner
A1  - Hawkins, Robert
A1  - Katz, Frieder
A1  - Balcke, Peter
A1  - Vermorken, Jan
A1  - Van Belle, Simon
A1  - Davidson, Neville
A1  - Esteve, Albert Abad
A1  - Castellano, Daniel
A1  - Kleeff, Jörg
A1  - Tempia-Caliera, Adrien A.
A1  - Kovar, Andreas
A1  - Nippgen, Johannes
T1  - A randomized multi-center phase II trial of the angiogenesis inhibitor Cilengitide (EMD 121974) and gemcitabine compared with gemcitabine alone in advanced unresectable pancreatic cancer
T2  - BMC Cancer 2006, 6:285
N2  - Background Anti-angiogenic treatment is believed to have at least cystostatic effects in highly vascularized tumours like pancreatic cancer. In this study, the treatment effects of the angiogenesis inhibitor Cilengitide and gemcitabine were compared with gemcitabine alone in patients with advanced unresectable pancreatic cancer. Methods A multi-national, open-label, controlled, randomized, parallel-group, phase II pilot study was conducted in 20 centers in 7 countries. Cilengitide was administered at 600 mg/m2 twice weekly for 4 weeks per cycle and gemcitabine at 1000 mg/m2 for 3 weeks followed by a week of rest per cycle. The planned treatment period was 6 four-week cycles. The primary endpoint of the study was overall survival and the secondary endpoints were progression-free survival (PFS), response rate, quality of life (QoL), effects on biological markers of disease (CA 19.9) and angiogenesis (vascular endothelial growth factor and basic fibroblast growth factor), and safety. An ancillary study investigated the pharmacokinetics of both drugs in a subset of patients. Results Eighty-nine patients were randomized. The median overall survival was 6.7 months for Cilengitide and gemcitabine and 7.7 months for gemcitabine alone. The median PFS times were 3.6 months and 3.8 months, respectively. The overall response rates were 17% and 14%, and the tumor growth control rates were 54% and 56%, respectively. Changes in the levels of CA 19.9 went in line with the clinical course of the disease, but no apparent relationships were seen with the biological markers of angiogenesis. QoL and safety evaluations were comparable between treatment groups. Pharmacokinetic studies showed no influence of gemcitabine on the pharmacokinetic parameters of Cilengitide and vice versa. Conclusion There were no clinically important differences observed regarding efficacy, safety and QoL between the groups. The observations lay in the range of other clinical studies in this setting. The combination regimen was well tolerated with no adverse effects on the safety, tolerability and pharmacokinetics of either agent.
Y1  - 2006
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/1743
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30-36576
N1  - This article is available from: http://www.biomedcentral.com/1471-2407/6/285 © 2006 Friess et al; licensee BioMed Central Ltd. 
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
VL  - 6
IS  - 285
ER  -