gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

A Prospective, Randomized trial Of Simultaneous Pancreatic cancer treatment with Enoxaparin and ChemoTherapy (PROSPECT – CONKO 004)

Meeting Abstract

  • corresponding author presenting/speaker Uwe Pelzer - Universitätsmedizin Berlin - Charité, Deutschland
  • A. Hilbig - Universitätsmedizin Berlin - Charité
  • J. Stieler - Universitätsmedizin Berlin - Charité
  • L. Roll - Universitätsmedizin Berlin - Charité
  • M. Stauch - Onkologische Schwerpunktpraxis Kronach
  • B. Opitz - Krankenhaus St. Elisabeth und St. Barbara Halle
  • T. Scholten - Krankenhaus Hagen
  • K. Zippel - Paritätisches Krankenhaus Lichtenberg
  • S. Hahnfeld - Onkologische Schwerpunktpraxis, Jena
  • B. Dörken - Universitätsmedizin Berlin - Charité
  • H. Riess - Universitätsmedizin Berlin - Charité
  • H. Oettle - Universitätsmedizin Berlin - Charité

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO136

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dkk2006/06dkk246.shtml

Veröffentlicht: 20. März 2006

© 2006 Pelzer et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Background: Approximately 20% of patients (pts) diagnosed with pancreatic adenocarcinoma (PA) develop venous thromboembolism, which may contribute to the dismal prognosis of PA. A published phase II trial showed us an improved survival by the addition of low molecular weight heparin (LMWH) to chemotherapy (Icli et al., ASCO 2003). The results of our pilot study indicate that the addition of enoxaparin to chemotherapy is safe and feasibel in pts with advanced PA. Furthermore, results of several phase III studies suggest that pts in good performance status may benefit from more intesive chemotherapy regimen (Riess et al; Heinemann et al; ASCO 2005). Based on these considerations we started the multicenter phase III study CONKO 004.

Patients and Methods: 540 patients are to be recruited into this study. There is a primary stratification according to general state and kidney function. Patients with good general state (KPS>80%) and normal kidney function receive GFFC +/- LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.). Pts with moderate general state and degraded kidney function receive the current standard therapy +/- LMWM (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w +/- Enoxaparin 1mg/kg daily s.c.) After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy +/- Enoxaparin 40mg daily s.c.

Results: Until October 2005 135 pts have been recruited in this study. First interim analysis planned after 12 pts. with deep vein thromboembolism. Now it has been reached. The analysis is ongoing.

Conclusions: The results of the initial pilot trial indicate that the addition of enoxaparin to GFFC is safe, does not change toxicity and maintains activity of chemotherapy in pts with advanced PA. Until today we can not publish results regarding overall survival. Results of the first interim analysis will be presented at the meeting.