The current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients with recurrent, pretreated ovarian cancer.
This study is a prospective open-label, non-randomized multicenter phase I/II trial in order to determine overall response rate of patients with platinum-resistant or refractory recurrent, pretreated epithelial ovarian cancer. In order to assure adequate toxicity assessment, a phase-I-trial is proponed. Phase II will be performed with MTD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Phase I Cyclophosphamid Pazopanib Dose level I 50 mg/day 400 mg/day Dose level II 50 mg/day 600 mg/day Dose level III 50 mg/day 800 mg/day Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally Phase II: Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally The dose for the phase II part of the trial will be based on the MTD of phase I.
Marienkrankenhaus Hamburg
Hamburg, Germany
Universitäts-Frauenklinik
Heidelberg, Germany
Klinikum Konstanz Gynäkologie und Geburtshilfe
Konstanz, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde
Mainz, Germany
Determination of the optimal doses for pazopanib (phase I)
Time frame: 42 months
Overall response rate according to RECIST criteria / clinical benefit (stable disease or partial response or complete response) (phase II)
Time frame: 12 weeks after start of treatment
Time to progression (TTP) according to RECIST criteria
Time frame: 7 years
Overall survival
Time frame: 7 years
Evaluation of CA125 tumour response
Time frame: 7 years
Number of patients with Adverse Events
Time frame: 7 years
Assessment of quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire
Time frame: 7 years
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Universitätsfrauenklinik Tübingen Klinik für Gynäkologie und Geburtshilfe
Tübingen, Germany