Rationale and design of PROSPECT-CONKO 004: a prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy)

doi:10.1186/1471-2407-8-361

BMC Cancer
Volume 8

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Riess H
Pelzer U
Hilbig A
Stieler J
Opitz B
Scholten T
Kauschat-Brüning D
Bramlage P
Dörken B
Oettle H

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Riess H
Pelzer U
Hilbig A
Stieler J
Opitz B
Scholten T
Kauschat-Brüning D
Bramlage P
Dörken B
Oettle H
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Study protocol

Rationale and design of PROSPECT-CONKO 004: a prospective, randomized trial of simultaneous pancreatic cancer treatment with enoxaparin and chemotherapy)

Hanno Riess^*¹ , Uwe Pelzer^*¹ , Andreas Hilbig¹ , Jens Stieler¹ , Bernhard Opitz² , Theo Scholten³ , Dörte Kauschat-Brüning⁴ , Peter Bramlage⁵ , Bernd Dörken¹ and Helmut Oettle¹

¹Charité Campus Virchow-Clinic, Medical Clinic Hematology/Oncology, Augustenburger Platz 1, 13353 Berlin, Germany

²Hospital St. Elisabeth/St. Barbara Halle, Mauerstraße 5, 06110 Halle (Saale), Germany

³Hospital Hagen, Grünstr. 35, 58095 Hagen, Germany

⁴Sanofi-Aventis Deutschland GmbH, Potsdamer Strasse 8, 10785 Berlin, Germany

⁵Institute for Clinical Pharmacology, Medical Faculty, TU Dresden, Fiedlerstrasse 27, 01307 Dresden, Germany

author email corresponding author email* Contributed equally

BMC Cancer 2008, 8:361doi:10.1186/1471-2407-8-361


Published:	5 December 2008

Abstract

Background

Advanced pancreatic cancer, in addition to its high mortality, is characterized by one of the highest rates of venous thromboembolic events (VTE) as compared to other types of cancer. Enoxaparin, a low molecular weight heparin (LMWH), has proven to be effective for the prevention and treatment of VTE in surgical and general medical patients. Results of some small studies suggest that this benefit might extend to patients with cancer, however, enoxaparin is not currently indicated for this use. This phase IIb study was designed to analyze the efficacy of enoxaparin in patients with locally advanced or metastatic pancreatic cancer undergoing systemic chemotherapy.

Methods

The aim of this prospective multicenter trial is to compare concomitant treatment with enoxaparin to no anticoagulation in 540 patients. Primary endpoint is the incidence of clinically relevant VTE (symptomatic deep venous thrombosis (DVT) of the leg and/or pelvic and/or pulmonary embolism (PE)) within the first 3 months. Secondary endpoints include the incidence of symptomatic and asymptomatic VTE after 6, 9 and 12 months as well as remission at 3, 6, 9 and 12 months, overall survival and bleeding. Trial registration: isrctn.org identifier CCT-NAPN-16752, controlled-trials.com identifier: ISRCTN02140505.

Results

An interim analysis for safety performed after inclusion of 152 patients revealed no increased risk of bleeding (5 pts vs. 6 pts, Chi²: 0.763).

Conclusion

PROSPECT is a pivotal study in elucidating the role of low molecular weight heparins in advanced pancreatic cancer. Its results will lead to a new understanding of the role of heparins in the prevention of venous thromboembolism and of their effect on survival, remission rates and toxicity of chemotherapeutic regimens.