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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
100mg/twice a day during chemotherapie,in maintenance phase 200 mg twice a day
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
Berlin, Germany
Progression-free survival
Time frame: every 3 months until PD
Objective tumor response rate (CR/PR (RECIST))
Time frame: During whole trial
Duration of response
Time frame: Until Progression of disease
Overall survival
Time frame: Until date of death
safety based on nature, frequency and severity of adverse events
Time frame: During treatment phase until resolution
Predose lonafarnib concentrations
Time frame: During treatment
PD activity
Time frame: Assessment
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