Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer
In Germany ovarian cancer belongs to the most frequently forms of cancer in the female
population. The prognosis for women with a platin refractory ovarian cancer is very bad. The
median survival time amounts for less a year. Especially in this palliative situation
therapies regarding efficacy as well as quality of life are needed. in Germany Topotecan is
approved since 1996 for patients after previous treatment with platin, the rare
non-hematological side-effects making it interesting for a palliative therapy. Since best
results in a chemo-therapeutical treatment are commonly obtained with the combination of two
or more cytostatic agents this study tests a Topotecan Monotherapy and two Topotecan
combinations. Both combination agents show efficacy alone against solid cancer using from
Topotecan different mechanism resulting in different main side effects. Total survival,
remission rates, time ti progression and quality of life are the main criteria investigated.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
Jalid Sehouli
Principal Investigator
Charité Campus Virchow Klinikum
Germany: Federal Institute for Drugs and Medical Devices
031000
NCT00312988
January 2000
December 2009
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