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Open Access Study protocol

A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer

Andre Mihaljevic1, Peter Büchler1*, Jan Harder2, Ralf Hofheinz5, Michael Gregor3, Stephan Kanzler4, Wolff Schmiegel6, Volker Heinemann7, Esther Endlicher8, Günter Klöppel9, Thomas Seufferlein10 and Michael Geissler11

Author Affiliations

1 Department of General Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg and Klinikum rechts der Isar, Technische Universität Munich, Ismaninger Strasse 22, 81675 Munich, Germany

2 Department of Gastroenterology and Hepatology, Freiburg University Hospital, Hugstetterstr, 55, 79106 Freiburg, Germany

3 Department of Internal Medicine I, University Clinic Tubingen, Ottfried-Müller-Str. 10, 72076 Tübingen, Germany

4 Department of Internal Medicine I, Johannes Gutenberg University, Langenbeckstr, 1, 55101 Mainz, Germany

5 III. Medical Clinic, University Hospital Mannheim, University of Heidelberg, Wiesbadener Strasse 7-11, 68167 Mannheim, Germany

6 Department of Medicine, Ruhr University Bochum (Knappschaftskrankenhaus), In der Schornau 23-25, 44892 Bochum, Germany

7 University of Munich, Medical Department III, Klinikum Muenchen-Grosshadern, Marchioninistrasse 15, 81377 Munich, Germany

8 Department of Internal Medicine I, University of Regensburg, Franz-Josef-Strauß-Allee, 93042 Regensburg, Germany

9 Department of Pathology, University of Kiel, Michaelisstr.11, 24105 Kiel, Germany

10 Department of Gastroenterology, University of Ulm, Robert-Koch-Str. 8, 89081 Ulm, Germany

11 Department of Medicine, Gastroenterology and Oncology, Municipal Hospital Esslingen, Germany

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BMC Surgery 2009, 9:1  doi:10.1186/1471-2482-9-1

Published: 8 January 2009

Abstract

Background

Pancreatic cancer is the fourth most common cause of cancer related death in Western countries. Advantages in surgical techniques, radiation and chemotherapy had almost no impact on the long term survival of affected patients. Therefore, the need for better treatment strategies is urgent. HER2, a receptor tyrosine kinase of the EGFR family, involved in signal transduction pathways leading to cell growth and differentiation is overexpressed in a number of cancers, including breast and pancreatic cancer. While in breast cancer HER2 has already been successfully used as a treatment target, there are only limited data evaluating the effects of inhibiting HER2 tyrosine kinases in patients with pancreatic cancer.

Methods

Here we report the design of a prospective, non-randomized multi-centered Phase II clinical study evaluating the effects of the Fluoropyrimidine-carbamate Capecitabine (Xeloda ®) and the monoclonal anti-HER2 antibody Trastuzumab (Herceptin®) in patients with non-resectable, HER2 overexpressing pancreatic cancer. Patients eligible for the study will receive Trastuzumab infusions on day 1, 8 and 15 concomitant to the oral intake of Capecitabine from day 1 to day 14 of each three week cylce. Cycles will be repeated until tumor progression. A total of 37 patients will be enrolled with an interim analysis after 23 patients.

Discussion

Primary end point of the study is to determine the progression free survival after 12 weeks of bimodal treatment with the chemotherapeutic agent Capecitabine and the anti-HER2 antibody Trastuzumab. Secondary end points include patient's survival, toxicity analysis, quality of life, the correlation of HER2 overexpression and clinical response to Trastuzumab treatment and, finally, the correlation of CA19-9 plasma levels and progression free intervals.