71
Participants
Start Date
July 31, 2013
Primary Completion Date
March 18, 2018
Study Completion Date
March 18, 2018
bevacizumab and trabectedin
Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients
bevacizumab, trabectedin and carboplatin
"Arm B: cycle 1- 6, bevacizumab given as 1 hour infusion will be followed by carboplatin AUC 4 and trabectedin 3 hour iv infusion.~Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion.~Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15.~From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days"
Azienda Ospedaliera Spedali Civili di Brescia, Brescia
Istituto Europeo di Oncologia, Milan
AO Fatebenefratelli e Oftalmico, Milan
Azienda Ospedaliera S. Gerardo, Monza
Istituto Oncologico Veneto, Padua
Policlinico Universitario Agostino Gemelli di Roma, Roma
Mauriziano Hospital, Torino
Collaborators (1)
PharmaMar
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Mario Negri Institute for Pharmacological Research
OTHER