The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with carboplatin and either pegylated liposomal doxorubicin or gemcitabine) in relation to the respective standard combination in patients with a KRAS wildtype with platinum-sensitive recurrent ovarian cancer. It is expected that the progression free survival rate at 12 months is improved by the targeted regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Panitumumab 6 mg/kg/BW d1 + 15 q4w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.
pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
Praxis Dr. Oettle
Friedrichshafen, Baden-Wurttemberg, Germany
RECRUITINGProgression-free survival (PFS) rate after 12 months.
PFS is defined as the time from randomisation to the time of disease progression or relapse (according to RECIST, not CA-125 only!) or death, or to the date of last tumor assessment without any such event (censored observation).
Time frame: 12 month
Duration of Tumor-Response
according to RECIST, including measurable disease patients only, and including patients with CA-125 defined disease as well
Time frame: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
Progression-free survival
Time frame: End of Follow-up (up to 1 year)
Overall survival
Time frame: End of Follow-up (up to 1 year)
Maximum toxicity resp. AE grade per patient per toxicity resp. AE during therapy
Toxicities resp. (S)AE during therapy will be documented, reported and analyzed according to NCI CTC 3.0 with special focus on skin toxicity. Results are given as maximum grade per patient per toxicity resp. AE during therapy.
Time frame: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
Tumor Response Rate
according to RECIST, including measurable disease patients only, and including patients with CA-125 defined disease as well
Time frame: Duration of Therapy (Therapy is planned for 6 cycles of 3 resp. 4 weeks each, shorter or longer durations are possible)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
Panitumumab 9 mg/kg/BW d1 q3w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.
Stauferklinikum Schwäbisch Gmünd
Mutlangen, Baden-Wurttemberg, Germany
RECRUITINGCarl-Thiem-Klinikum Cottbus Frauenklinik
Cottbus, Brandenburg, Germany
RECRUITINGPraxis Dr. Heinrich
Fürstenwalde, Brandenburg, Germany
RECRUITINGTagesklinik Altonaer Strasse
Hamburg, Hamburg, Germany
RECRUITINGMVM mbH Onkologische Schwerpunktpraxis Leer
Leer, Lower Saxony, Germany
RECRUITINGUniversitätsfrauenklinik am Klinikum Südstadt
Rostock, Mecklenburg-Vorpommern, Germany
WITHDRAWNMedizinisches Zentrum Bonn-Friedensplatz
Bonn, North Rhine-Westphalia, Germany
RECRUITINGKlinikum Chemnitz Frauen- und Kinderklinik
Chemnitz, Saxony, Germany
RECRUITINGMartin-Luther-Universität Halle-Wittenberg Zentrum für Frauenheilkunde und Geburtshilfe
Halle, Saxony-Anhalt, Germany
RECRUITING...and 8 more locations