Spots Global Cancer Trial Database for Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
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Trial Identification
Brief Title: Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
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
Study ID: NCT00102375
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Gynecologic Hospital of the Medical Facilities RWTH, Aachen, , Germany
Clinic for Gynecology and Gyn. Oncology, Humboldt University, Berlin, , Germany
University Clinic Carl Gustav Carus, Gynecological hospital, Dresden, , Germany
Gynecologic Hospital, Duesseldorf, , Germany
University Gynecologic Hospital, Duesseldorf, , Germany
University Gynecologic Hospital, Frankfurt, , Germany
Gynecologic Clinic of the Ernst-Moritz-Arndt-University, Greifswald, , Germany
University Gynecologic Hospital, Göttingen, , Germany
Gynecological Clinic of the Medical University, Hannover, , Germany
St. Vincentius Gynecologic Hospital, Karlsruhe, , Germany
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics, Kiel, , Germany
Otto-von-Guericke University, University Gynecological Hospital, Magdeburg, , Germany
University Gynecologic Hospital Grosshadern, Muenchen, , Germany
University Gynecologic Hospital "rechts der Isar", Muenchen, , Germany
Clinic for Gynecology, Muenster, , Germany
University Gynecologic Hospital, Tuebingen, , Germany
University Gynecological Hospital, Ulm, , Germany
Clinic for Gnyecology and gyn. Oncology HSK, Wiesbaden, , Germany
Contact Details
Name: Jacobus Pfisterer, Prof. Dr.
Affiliation: AGO Study Group
Role: PRINCIPAL_INVESTIGATOR
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