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Sponsored by: |
AGO Ovarian Cancer Study Group |
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Information provided by: | AGO Ovarian Cancer Study Group |
ClinicalTrials.gov Identifier: | NCT00102375 |
The purpose of this study is to determine whether the triple combination of Carboplatin, Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: Topotecan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan |
Estimated Enrollment: | 900 |
Study Start Date: | December 1999 |
Estimated Study Completion Date: | October 2004 |
Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. One option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. In two separate, single center phase II studies, a different combination of the three active agents (Carboplatin, Paclitaxel and Topotecan) has been tested. In these studies, Carboplatin and Paclitaxel were given at standard doses and schedules, followed sequentially by Topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good.
Study Hypothesis/Comparison: The triple combination (Carboplatin/Paclitaxel/Topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin + Paclitaxel
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate hematologic, renal and hepatic function:
Exclusion Criteria:
Germany | |
Clinic for Gnyecology and gyn. Oncology HSK | |
Wiesbaden, Germany, 65199 | |
Clinic for Gynecology and Gyn. Oncology, Humboldt University | |
Berlin, Germany, 10117 | |
Gynecologic Clinic of the Ernst-Moritz-Arndt-University | |
Greifswald, Germany, 17487 | |
Gynecologic Hospital | |
Duesseldorf, Germany, 40217 | |
Otto-von-Guericke University, University Gynecological Hospital | |
Magdeburg, Germany, 39108 | |
University Clinic Carl Gustav Carus, Gynecological hospital | |
Dresden, Germany, 01307 | |
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics | |
Kiel, Germany, 24105 | |
University Gynecologic Hospital | |
Frankfurt, Germany, 60596 | |
University Gynecological Hospital | |
Ulm, Germany, 89075 | |
University Gynecologic Hospital | |
Tuebingen, Germany, 72076 | |
University Gynecologic Hospital Grosshadern | |
Muenchen, Germany, 81377 | |
University Gynecologic Hospital "rechts der Isar" | |
Muenchen, Germany, 81675 | |
Gynecological Clinic of the Medical University | |
Hannover, Germany, 30659 | |
University Gynecologic Hospital | |
Göttingen, Germany, 37075 | |
St. Vincentius Gynecologic Hospital | |
Karlsruhe, Germany, 76137 | |
University Gynecologic Hospital | |
Duesseldorf, Germany, 40225 | |
Gynecologic Hospital of the Medical Facilities RWTH | |
Aachen, Germany, 52074 | |
Clinic for Gynecology | |
Muenster, Germany, 48149 |
Principal Investigator: | Jacobus Pfisterer, Prof. Dr. | AGO Ovarian Cancer Study Group |
Study ID Numbers: | AGO-OVAR 7 |
Study First Received: | January 29, 2005 |
Last Updated: | August 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00102375 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Ovarian Cancer first-line Topotecan |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Antimitotic Agents Carboplatin Ovarian Diseases Ovarian Epithelial Cancer |
Carcinoma Genital Diseases, Female Paclitaxel Tubulin Modulators Ovarian Cancer Endocrinopathy Topotecan Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |
Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Mitosis Modulators Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Urogenital Neoplasms Antimitotic Agents Ovarian Diseases Carboplatin |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Topotecan Antineoplastic Agents, Phytogenic Endocrine Gland Neoplasms |