Spots Global Cancer Trial Database for Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer
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Trial Identification
Brief Title: Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer
Official Title: Lapatinib Versus Lapatinib With Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A Randomized Phase II Trial
Study ID: NCT01145404
Conditions
Study Description
Brief Summary: Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a beneficial contribution to current treatment paradigms since preclinical data suggest that lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines, which may contribute to clinical benefit. The study described in this protocol has been designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to search for molecular correlates that may be associated with response to this compound. The majority of patients with metastatic gastric and gastro-esophageal cancer undergo first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes combined to a taxane), but the role of second-line chemotherapy has not yet been defined. Therefore, progression during or shortly after first-line chemotherapy is a medical condition no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and gastroesophageal cancer make these indications prime candidate for treatment with the dual ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHARITÉ CAMPUS, VIRCHOW-KLINIKUM, UNIVERSITÄTSMEDIZIN BERLIN, Centrum 14, Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Berlin, , Germany
Evangelisches Krankenhaus Bielefeld gGmbH, Klinik für Innere Medizin, Hämatologie/Onkologie und Palliativmedizin, Bielefeld, , Germany
Medizinische Uniklinik, Knappschaftskrankenhaus Bochum, Bochum, , Germany
Evangelische Kliniken Bonn gGmbH, Johanniter-Krankenhaus, Bonn, , Germany
Städtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Kliniken Essen Mitte, Department of Medical Oncology and Hematology, Essen, , Germany
Klinikum Esslingen, Klinik für Allgemeine Innere Medizin, Onkologie und Gastroenterologie, Esslingen, , Germany
Krankenhaus Nord West, Frankfurt, , Germany
Universitätsklinikum Halle, Klinik für Innere Medizin IV, Halle, , Germany
OncoResearch Lerchenfeld UG, Hamburg, , Germany
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie, Endokrinologie, Hannover, , Germany
NCT Heidelberg, Heidelberg, , Germany
I. Med. Klinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität, Mainz, , Germany
Universitätsklinikum Gießen und Marburg GmbH, Marburg, , Germany
Klinikum rechts der Isar, München, , Germany
Klinikum Regensburg, Klinik und Poliklinik für Innere Medizin I, Regensburg, , Germany
Contact Details
Name: Florian Lordick, MD
Affiliation: Academic Teaching Hospital Braunschweig
Role: STUDY_DIRECTOR
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