Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

March 18, 2018

Study Completion Date

March 18, 2018

Conditions
Ovarian Epithelial Cancer Recurrent
Interventions
DRUG

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

DRUG

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"

Trial Locations (7)

Unknown

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PharmaMar

INDUSTRY

collaborator

Hoffmann-La Roche

INDUSTRY

lead

Mario Negri Institute for Pharmacological Research

OTHER