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Open Access Highly Accessed Study protocol

The PACOVAR-trial: A phase I/II study of pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant recurrent, pre-treated ovarian cancer

Michael Eichbaum1*, Christine Mayer1, Regina Eickhoff2, Esther Bischofs1, Gerhard Gebauer3, Tanja Fehm4, Florian Lenz5, Hans-Christian Fricke6, Erich Solomayer7, Nikos Fersis8, Marcus Schmidt9, Markus Wallwiener1, Andreas Schneeweiss110 and Christof Sohn1

Author Affiliations

1 University of Heidelberg Medical School, Department of Gynecology and Obstetrics, Voss-Str. 9, 69115 Heidelberg, Germany

2 Alcedis GmbH, Winchesterstraße 2, 35394 Gießen, Germany

3 Klinik für Gynäkologie und gynäkologische Onkologie, Marienkrankenhaus Hamburg, Alfredstraße 9, 22087 Hamburg, Germany

4 University of Tuebingen Medical School, Department of Gynecology and Obstetrics, Calwerstraße 7, 72076 Tuebingen, Germany

5 Frauenklinik Krankenhaus Hetzelstift Neustadt, Stiftstraße 10, 67434 Neustadt an der Weinstraße, Germany

6 Frauenklinik Klinikum Konstanz, Luisenstraße 7, 78464 Konstanz, Germany

7 University of Homburg/Saar Medical School, Department of Gynecology and Obstetrics, 66424 Homburg/Saar, Germany

8 Frauenklinik Klinikum Chemnitz gGmbH, Flemmingstraße 4, 09116 Chemnitz, Germany

9 University of Mainz Medical School, Department of Gynecology and Obstetrics, Langenbeckstr. 1, 55131 Mainz, Germany

10 National Center for Tumor Diseases, University Hospital, Im Neuenheimer Feld 460, 69120 Heidelberg, Germany

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BMC Cancer 2011, 11:453  doi:10.1186/1471-2407-11-453

Published: 20 October 2011

Abstract

Background

The prognosis of patients with recurrent, platinum-resistant epithelial ovarian cancer (EOC) is poor. There is no standard treatment available. Emerging evidence suggests a major role for antiangiogenic treatment modalities in EOC, in particular in combination with the metronomic application of low dose chemotherapy. The novel, investigational oral antiangiogenic agent pazopanib targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and c-kit is currently being studied in different tumour types and is already used as first line therapy in recurrent renal cell carcinoma. A combined therapy consisting of pazopanib and metronomic oral cyclophosphamide may offer a well-tolerable treatment option to patients with recurrent, pretreated EOC.

Methods/design

This study is designed as a multicenter phase I/II trial evaluating the optimal dose for pazopanib (phase I) as well as activity and tolerability of a combination regimen consisting of pazopanib and metronomic cyclophosphamide in the palliative treatment of patients with recurrent, platinum-resistant, pre-treated ovarian cancer (phase II). The patient population includes patients with histologically or cytologically confirmed diagnosis of EOC, cancer of the fallopian tube or peritoneal cancer which is platinumresistant or -refractory. Patients must have measurable disease according to RECIST criteria and must have failed available standard chemotherapy. Primary objectives are determination of the optimal doses for pazopanib (phase I) and the overall response rate according to RECIST criteria (phase II). Secondary objectives are time to progression, overall survival, safety and tolerability. The treatment duration is until disease progression or intolerability of study drug regimen (with a maximum of 13 cycles up to 52 weeks per subject).

Discussion

The current phase I/II trial shall clarify the potential of the multitargeting antiangiogenic tyrosinkinaseinhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients with recurrent, pretreated ovarian cancer.

Trial registration

ClinicalTrials.gov: NCT01238770