gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Anti-angiogenesis Treatment with PTK/ZK in Ovarian Cancer: A Phase IB, Open Label, Safety and Pharmacokinetics (PK) Study of Escalating Doses of PTK787/ZK 222584 (PTK/ZK) in Combination With Paclitaxel and Carboplatin in Patients (pts) With Stage IC to IV Epithelial Ovarian Cancer

Meeting Abstract

  • corresponding author presenting/speaker Willibald Schröder - Klinikum Bremen-Mitte, Bremen, Deutschland
  • Sophie Abadie - Centre Paul Papin, Angers, France
  • P. O. Witteveen - UMC Utrecht, Utrecht, The Netherlands
  • Mario Campone - Centre Rene Gauducheau, Nantes, France
  • Patrice Viens - Institut Paoli Calmettes, Marseille, France
  • Tarja Jalava - Schering AG, Berlin
  • Eric Masson - Novartis Pharmaceuticals, East Hanover, NJ, USA
  • Sanela Bilic - Novartis Pharmaceuticals, East Hanover, NJ, USA
  • Dirk Laurent - Schering AG, Berlin
  • Andreas du Bois - Dr. Horst Schmidt Kliniken, Wiesbaden

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO447

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter:

Veröffentlicht: 20. März 2006

© 2006 Schröder et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen ( Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.



Background: Vascular endothelial growth factors (VEGFs) and VEGF receptors (VEGFRs) are important mediators of tumor growth and metastasis and their expression is associated with poor prognosis in epithelial ovarian cancer. PTK/ZK is a novel, oral, angiogenesis and lymphangiogenesis inhibitor that blocks tyrosine kinase signaling from all known VEGFRs.

Methods: An open-label, multicenter, phase-IB, dose-escalation study evaluated PTK/ZK with chemotherapy as first line-therapy in pts with stage IC-IV epithelial ovarian cancer. Paclitaxel was administered as a 3-hour infusion on day 1 of each 21-day cycle at 175 mg/m2. Carboplatin was given immediately after paclitaxel as a 30-min IV infusion to an AUC of 5 mg min/mL. PTK/ZK was given daily from day 3-21 of each cycle. Cohorts of 3 to 6 pts received doses of PTK/ZK at 250, 500, 750, 1,000 or 1,250 mg/day. MTD and DLT of PTK/ZK were assessed; PK of PTK/ZK, carboplatin and paclitaxel was characterized.

Results: 19 pts were evaluated; 16 for DLT; 18 for PK. No DLTs or PTK/ZK-related SAEs were reported. One pt discontinued due to AEs. Grade 1-2 hypertension was the most common AE. Steady-state PTK/ZK plasma levels were constant between cycle 1-2. PTK/ZK has no impact on systemic exposure of free platinum. Paclitaxel exposure was not affected at the biologically active dose of 1,250 mg/day PTK/ZK. Additional data are being collected at the 1,250 mg dose level.

Conclusion: PTK/ZK with paclitaxel and carboplatin is feasible and shows acceptable safety. Updated data will be presented.