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Original Article · Originalarbeit

Immunotherapy of Peritoneal Carcinomatosis with the Antibody Catumaxomab in Colon, Gastric, or Pancreatic Cancer: An Open-Label, Multicenter, Phase I/II Trial

Ströhlein M.A.a · Lordick F.b · Rüttinger D.c · Grützner K.a · Schemanski O.C.a · Jäger M.d · Lindhofer H.e · Hennig M.f · Jauch K.c · Peschel C.g · Heiss M.M.a

Author affiliations

aDepartment of Abdominal, Vascular and Transplant Surgery, Cologne Merheim Medical Center, University of Witten-Herdecke, Cologne, bDepartment of Medical Oncology, National Center for Tumor Disease, University of Heidelberg, cDepartment of Surgery, Klinikum Groβhadern, Ludwig Maximilians University Munich, dTRION Research GmbH, Martinsried, eTRION Pharma GmbH, fFresenius Biotech GmbH, Munich, gDepartment of Hematology and Medical Oncology, Klinikum rechts der Isar, Technical University Munich, Germany

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Onkologie 2011;34:101–108

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Article / Publication Details

First-Page Preview
Abstract of Original Article · Originalarbeit

Published online: February 18, 2011
Issue release date: March 2011

ISSN: 2296-5270 (Print)
eISSN: 2296-5262 (Online)

For additional information: https://www.karger.com/ORT

Abstract

Background: Peritoneal carcinomatosis (PC) is common in gastrointestinal (GI) cancer and there is no effective standard treatment. We investigated the tolerability and maximum tolerated dose (MTD) of the trifunctional antibody catumaxomab in patients with PC. Methods: In this openlabel, phase I/II clinical trial, patients with epithelial cell adhesion molecule (EpCAM)-positive PC from GI cancer received 4 sequential intraperitoneal catumaxomab infusions: day 0: 10 µg; day 3: 10 or 20 µg; day 7: 30, 50, or 100 µg; and day 10: 50, 100, or 200 µg. Dose escalation was guided by dose-limiting toxicities. Results: The MTD was 10, 20, 50, and 200 µg on days 0, 3, 7, and 10, respectively. Catumaxomab had an acceptable safety profile: Most common treatment-related adverse events (at the MTD) were fever, vomiting, and abdominal pain. At final examination, 11/17 evaluable patients (65%) were progression free: 1 patient had a complete and 3 a partial response. Median overall survival from the time of diagnosis of PC was 502 days. Conclusions: Intraperitoneal catumaxomab is a promising option for the treatment of PC from GI cancer.

© 2011 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Original Article · Originalarbeit

Published online: February 18, 2011
Issue release date: March 2011

ISSN: 2296-5270 (Print)
eISSN: 2296-5262 (Online)

For additional information: https://www.karger.com/ORT


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