Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors
- Conditions
- Ovarian CancerEndometrial Cancer
- Registration Number
- NCT00569257
- Lead Sponsor
- AEterna Zentaris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 85
- LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor
- Histologically confirmed epithelial ovarian cancer (Stratum A)
- Advanced (FIGO III or IV) or recurrent disease
- Progression during treatment with a platinum-based regimen or within 6 months after receiving a platinum-based regimen
- Previous treatment with a taxane-containing regimen
- At least one measurable target lesion (RECIST criteria) OR CA125 level higher than twice the upper limit of normal range (GCIG criteria)
- Histologically confirmed endometrial cancer (Stratum B)
- Advanced (FIGO III or IV) or recurrent disease not amenable to potentially curative treatment with local surgery and/or radiation therapy
- No previous anthracycline-based chemotherapy
- At least one measurable target lesion according to RECIST criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria up to six 3-weekly treatment cycles
- Secondary Outcome Measures
Name Time Method Time-to-progression (TTP); Overall survival up to observation of event Safety of AEZS-108 (possibly drug-related adverse events) 4 weeks beyond last drug admnistration
Trial Locations
- Locations (17)
Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Frauenklinik, St. Vincentius Kliniken AG
🇩🇪Karlsruhe, Germany
Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg
🇩🇪Erlangen, Germany
Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt
🇩🇪Frankfurt / Main, Germany
Frauenklinik, Klinikum Bremen-Mitte GmbH
🇩🇪Bremen, Germany
Frauenklinik, Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik
🇩🇪Rostock, Germany
Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH
🇩🇪Wiesbaden, Germany
Frauenklinik, Klinikum Lüneburg
🇩🇪Lüneburg, Germany
Universitätsfrauenklinik, Universitätsklinikum
🇩🇪Essen, Germany
Regional Oncodispensary "M.Markov"
🇧🇬Varna, Bulgaria
University Hospital "Dr. Georgy Stranski"
🇧🇬Pleven, Bulgaria
Regional Oncology Hospital Plovdiv
🇧🇬Plovdiv, Bulgaria
Frauenklinik, Georg-August-Universität Göttingen
🇩🇪Göttingen, Germany
Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe
🇩🇪Greifswald, Germany