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
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival
Jacobus Pfisterer, Prof. Dr.
Principal Investigator
AGO Study Group
Germany: Federal Institute for Drugs and Medical Devices
AGO-OVAR 7
NCT00102375
December 1999
October 2004
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