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The purpose of this study is to compare the effects of Paclitaxel/Carboplatin and Lonafarnib to those of Paclitaxel/Carboplatin in primary treatment of patients with epithelial ovarian cancer.
Today the standard therapy for patients with advanced ovarian carcinoma is paclitaxel and carboplatin. Lonafarnib is a farnesyl transferase inhibitor (FTI) that is active against a broad spectrum of tumor cell lines in vitro and tumor xenografts in nude mice. Lonafarnib has single-agent antitumor activity as well as enhanced activity in combination with taxanes in a number of tumor cell lines and in vivo models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lonafarnib / Paclitaxel /Carboplatin | Experimental |
| |
| Paclitaxel/Carboplatin | Other | Standard Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lonafarnib | Drug | 100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | every 3 months until PD |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate (CR/PR (RECIST)) | During whole trial | |
| Duration of response | Until Progression of disease | |
| Overall survival |
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Inclusion Criteria:
WBC >= 3.0 x 10^9/l; Neutrophils (ANC) >= 1.5 x 10^9/l; Platelets >= 100 x 10^9/l; Hemoglobin > 6 mmol/l (> 10.0 g/dl); Bilirubin <= 1 x upper limit of normal range; Alkaline phosphatase <= 2.5 x upper limit of normal range; estimated GFR >= 50 ml/min according to Jelliffe or Cockroft-Gault formula
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Meier, Prof. Dr. | Ev. Krankenhaus, Düsseldorf, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde | Berlin | 13353 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22564713 | Result | Meier W, du Bois A, Rau J, Gropp-Meier M, Baumann K, Huober J, Wollschlaeger K, Kreienberg R, Canzler U, Schmalfeldt B, Wimberger P, Richter B, Schroder W, Belau A, Stahle A, Burges A, Sehouli J. Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV. Gynecol Oncol. 2012 Aug;126(2):236-40. doi: 10.1016/j.ygyno.2012.04.050. Epub 2012 May 4. |
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| Until date of death |
| safety based on nature, frequency and severity of adverse events | During treatment phase until resolution |
| Predose lonafarnib concentrations | During treatment |
| PD activity | Assessment |
| Klinikum Bremen Mitte, Frauenklinik |
| Bremen |
| 28177 |
| Germany |
| Carl-Gustav-Carus der TU Dresden, Universitäts-Frauenklinik | Dresden | 01307 | Germany |
| Ev. Krankenhaus, Frauenklinik | Düsseldorf | 40217 | Germany |
| Klinik für Frauenheilkunde der Univ. Erlangen | Erlangen | 91054 | Germany |
| Universitätsfrauenklinik | Essen | 45147 | Germany |
| Klinikum der Johann Wolfgang Goethe Universität, Klinik für Frauenheilkunde u. Geburtshilfe | Frankfurt | 60590 | Germany |
| Universitätsklinikum Freiburg, Frauenklinik | Freiburg im Breisgau | 79106 | Germany |
| Kreiskrankenhaus, Frauenklinik | Gifhorn | 38518 | Germany |
| Klinik u. Poliklinik für Gynäkologie und Geburtshilfe | Greifswald | 17487 | Germany |
| Medizinische Hochschule | Hanover | 30625 | Germany |
| St. Vincentius-Krankenhäuser | Karlsruhe | 76137 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynäkologie und Geburtshilfe | Kiel | 24105 | Germany |
| Klinik der Otto-von-Guericke Universität, Frauenklinik | Magdeburg | 39108 | Germany |
| Johannes-Gutenberg-Universität, Universitäts-Frauenklinik | Mainz | 55101 | Germany |
| Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie | Marburg | 35037 | Germany |
| Klinikum Großhadern, Frauenklinik | München | 81377 | Germany |
| Klinikum rechts der Isar der TU München | München | 81675 | Germany |
| Elblandkliniken, Frauenklinik | Radebeul | 01445 | Germany |
| Klinikum Südstadt | Rostock | 18059 | Germany |
| Universitäts-Frauenklinik | Tübingen | 72076 | Germany |
| Universitätsfrauenklinik | Ulm | 89075 | Germany |
| Dr. Horst Schmidt Klinik, Gynäkologie u. Gynäkologische Onkologie | Wiesbaden | 65199 | Germany |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C115354 | lonafarnib |
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