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The purpose of this study is to determine the activity, tolerability and safety of Temsirolimus in women with ovarian cancer who progressed during the previous platinum chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temsirolimus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temsirolimus | Drug | 25mg weekly intravenous until progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | after 4 months for ovarian cancer and 6 months for endometrial carcinoma after study entry |
| Measure | Description | Time Frame |
|---|---|---|
| rate and duration of stable diseases according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and Gynecologic Cancer Intergroup (GCIG)-criteria for ovarian cancer | every 8 weeks until progression | |
| progression-free survival according to RECIST 1.1 and cancer antigen 125 (CA 125) (for ovarian cancer) (biological progression-free survival (PFSbio)) |
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Inclusion Criteria:
Stratum A - Ovarian Cancer:
Stratum B - Endometrian Cancer:
Exclusion Criteria:
Applicable only for patients with no hysterectomy and/or bilateral adnexectomy prior to start of study.
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| Name | Affiliation | Role |
|---|---|---|
| Günter Emons, Professor | AGO Study Group (Study Group of the Arbeitsgemeinschaft Gynaekologische Onkologie) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89075 | Germany | ||
| Universität Erlangen-Nürnberg |
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| Label | URL |
|---|---|
| Final publication | View source |
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| every 8 weeks until progression |
| overall survival | weekly until progression; thereafter every 8 weeks |
| safety and toxicity, i.e. type, frequency, severity and duration of adverse reactions | weekly until progression; thereafter every 8 weeks |
| quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) questionaires "QLQ C30", "QLQ OV28" and "QLQ-EN24" | every 8 weeks |
| rate and duration of stable diseases according to RECIST-criteria for endometrial cancer | every 8 weeks until progression |
| Erlangen |
| Bavaria |
| 91054 |
| Germany |
| Klinikum rechts der Isar der Technischen Universität | München | Bavaria | 81675 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20251 | Germany |
| GYNAEKOLOGICUM Bremen | Bremen | Free Hanseatic City of Bremen | 28211 | Germany |
| Klinikum der J. W. Goethe-Universität | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitätsklinikum Gießen-Marburg, Standort Marburg | Marburg | Hesse | 35043 | Germany |
| Klinikum Offenbach | Offenbach | Hesse | 63069 | Germany |
| Klinikum Göttingen, Georg-August-Universität | Göttingen | Lower Saxony | 37075 | Germany |
| Gynäkologisch-onkologische Praxis | Hanover | Lower Saxony | 30177 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH | Essen | North Rhine-Westphalia | 45136 | Germany |
| Städt. Klinikum Solingen gGmbH | Solingen | North Rhine-Westphalia | 42653 | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charité, Campus Virchow Klinikum | Berlin | State of Berlin | 13353 | Germany |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D010049 | Ovarian Diseases |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| C401859 | temsirolimus |
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