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Brief Title: Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors
Official Title: Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors
Study ID: NCT00569257
Brief Summary: The purpose of this study is to determine whether AEZS-108 shows anti-tumor activity and is tolerated in patients with gynecological tumors (ovarian / endometrial cancer) that have been shown to express receptors for the luteinizing hormone releasing hormone (LHRH)
Detailed Description: The ovary and the endometrium are hormone dependent organs. Receptors for different sex hormones are found commonly in epithelial ovarian and endometrial cancers. LHRH and its receptors are expressed in about 80% of human ovarian and endometrial cancers. As binding sites are present on tumors in higher concentrations than on most normal tissues, these receptors represent a specific target for AEZS-108 in which doxorubicin is coupled to an LHRH analog. Patients whose tumor specimen have shown to be positive for LHRH receptor expression will be investigated for tumor response and tolerability.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University Hospital "Dr. Georgy Stranski", Pleven, , Bulgaria
Regional Oncology Hospital Plovdiv, Plovdiv, , Bulgaria
Regional Oncodispensary "M.Markov", Varna, , Bulgaria
Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum, Berlin, , Germany
Frauenklinik, Klinikum Bremen-Mitte GmbH, Bremen, , Germany
Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg, Erlangen, , Germany
Universitätsfrauenklinik, Universitätsklinikum, Essen, , Germany
Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt, Frankfurt / Main, , Germany
Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe, Greifswald, , Germany
Frauenklinik, Georg-August-Universität Göttingen, Göttingen, , Germany
Frauenklinik, Medizinische Hochschule Hannover, Hannover, , Germany
Frauenklinik, St. Vincentius Kliniken AG, Karlsruhe, , Germany
Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, , Germany
Frauenklinik, Klinikum Lüneburg, Lüneburg, , Germany
Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik, Rostock, , Germany
Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH, Wiesbaden, , Germany
Name: Günter Emons, Prof.Dr.med.
Affiliation: Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen
Role: PRINCIPAL_INVESTIGATOR