An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer, Trabectedin, Yondelis, Advanced Relapsed Ovarian Cancer, DOXIL, CAELYX
Eligibility Criteria
Inclusion Criteria: Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer Prior treatment with only 1 platinum based chemotherapy regimen Eastern Cooperative Oncology Group status of not more than 2 Progression more than 6 months after the start of initial chemotherapy treatment Exclusion Criteria: Treatment with more than 1 prior chemotherapy regimen Progression within 6 months after starting initial chemotherapy Prior exposure to anthracyclines Unwilling or unable to have central venous catheter Known clinically relevant central nervous system metastasis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DOXIL + trabectedin
DOXIL
Combination arm - Trabectedin + DOXIL: DOXIL 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. patients will be premedicated with 20 mg dexamethasone or its equivalent IV infusion over 30 minutes prior to the DOXIL infusion.
Monotherapy arm - DOXIL: 50 mg/m2 IV infusion over 90 minutes every 4 weeks.