Spots Global Cancer Trial Database for Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)
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Trial Identification
Brief Title: Gemcitabine and Sorafenib in Advanced Biliary Tract Cancer (GEMSO)
Official Title: A Randomized, Double-blind, Multicenter Phase II Trial With Gemcitabine Plus Sorafenib Versus Gemcitabine Plus Placebo in Patients With Chemo-naive Advanced or Metastatic Adenocarcinoma of the Biliary Tract
Study ID: NCT00661830
Conditions
Study Description
Brief Summary: This trial will be conducted to evaluate the efficacy, safety and tolerability of a combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong scientific rationale for exploring the role of sorafenib in combination with gemcitabine in advanced CCC. Sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2, R3 and PDGFR-β. Mutations in these signaling pathways display by far the most common genetic alterations in CCC and overexpression correlates to poor prognosis. Furthermore, there is no evidence of a consistent or meaningful pharmacokinetic interaction between sorafenib and gemcitabine, suggesting that sorafenib can safely be combined with gemcitabine. Clinical results of a combination of sorafenib and gemcitabine in a phase I study in pancreatic cancer suggested a therapeutic effect, and the safety and efficacy results together with the knowledge of the molecular pathology of CCC provide a rationale for a randomized, placebo-controlled phase II trial consisting of gemcitabine plus sorafenib in advanced CCC.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinikum der Johannes Gutenberg-Universität Mainz, I. Med. Klinik, Mainz, Rheinland-Pfalz, Germany
Universitätsklinikum Jena, Klinik für Innere Medizin, Innere Medizin II, D-07740 Jena, , Germany
Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik, Zentrum für Innere Medizin, Martinistr. 3, D-20248 Hamburg, , Germany
Klinikum Fulda gAG, Tumorklinik, Pacelliallee 4, D-36043 Fulda, , Germany
Klinikum der Johann-Wolfgang Goethe-Universität, Innere Medizin I, Theodor-Stern-Kai 7, D-60590 Frankfurt, , Germany
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Kirrberger Str., Gebäude 41, D-66421 Homburg/Saar, , Germany
Klinikum der Universität München, Medizinische Klinik II, Marchioninistr. 15, D-81377 München, , Germany
Klinikum rechts der Isar, TU München, II. Medizinische Klinik und Poliklinik, Ismaningerstr. 22, D-81675 München, , Germany
II. Med. Klinik, Leopoldina-Krankenhaus der Stadt Schweinfurt, Gustav-Adolf-Str. 8, D-97422 Schweinfurt, , Germany
Klinikum Esslingen, Esslingen, , Germany
Universitätsklinikum Halle, Innere Medizin I, Halle, , Germany
Contact Details
Name: Markus Moehler, MD
Affiliation: Johannes Gutenberg University Mainz, I. Med. Klinik
Role: PRINCIPAL_INVESTIGATOR
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