Spots Global Cancer Trial Database for TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer
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Trial Identification
Brief Title: TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer
Official Title: A Randomized Phase II Trial of Irinotecan Drug-eluting Beads Administered by Hepatic Chemoembolization With Intravenous Cetuximab (DEBIRITUX) Versus Systemic Treatment With Intravenous Cetuximab and Irinotecan in Patients With Refractory Metastatic Colorectal Cancer and K-ras Wild-type Tumours
Study ID: NCT01060423
Conditions
Study Description
Brief Summary: The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with unresectable liver metastases from colorectal cancer. Secondary objectives are safety and tolerability of hepatic chemoembolization and the question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and emesis.
Detailed Description: About half of patients with newly diagnosed colorectal cancer will develop metastatic disease and, however, in spite of the significant progress in the therapeutical strategies for metastatic disease, virtually all patients will eventually succumb to their illness. Based on prior clinical data there is a good rationale for the expectation that the combination of systemic chemotherapy and arterial chemoembolization with drug eluting beads may be effective in the setting of patients with unresectable or chemorefractory liver metastases. The aim of this study is therefore to assess whether the combination of Irinotecan eluting beads and intravenous cetuximab is safe and effective in the treatment of patients with unresectable liver metastases from refractory colorectal cancer and will result in a prolongation of disease control when compared to standard systemic treatment with intravenous irinotecan and intravenous cetuximab. In this patient group, intravenous irinotecan plus intravenous cetuximab may represent the "standard of care", with a previously described activity. The patient group is defined in terms of pretreatment, and the scientific question is whether the way of irinotecan administration by eluting beads in feasible and somehow beneficial.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Zentralklinik Bad Berka GmbH, Abteilung fĂźr Interventionelle Radiologie, Bad Berka, , Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, , Germany
Kliniken Essen-Mitte, Klinik fĂźr Innere Medizin IV, Essen, , Germany
Klinikum Esslingen, Klinik fĂźr Onkologie, Gastroenterologie und Allgemeine Innere Medizin, Esslingen, , Germany
Krankenhaus Nordwest, Frankfurt/M., , Germany
Universitätsklinikum der Johann Wolfgang Goethe Universität Frankfurt, Frankfurt/M., , Germany
Martin-Luther-Universität Halle-Wittenberg, Halle (Saale), , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
SLK-Kliniken Heilbronn, Heilbronn, , Germany
Otto-von-Guericke-Universität Magdeburg, Magdeburg, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Universitätsklinikum Tßbingen, Medizinische Klinik und Poliklinik II, Tßbingen, , Germany
Universitätsklinikum Wßrzburg, Institut fßr RÜntgendiagnostik, Wßrzburg, , Germany
Contact Details
Name: Dirk Arnold, MD
Affiliation: Universitätsklinikum Eppendorf, Universitäres Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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