Reprab Study: PLD + Trabectedin Rechallenge

Inclusion Criteria

• •Female aged ≥ 18 years.
• •Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
• •Platinum partially sensitive patients or fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments, who have previously received pegylated liposomal doxorubicin (carboplatin- pegylated liposomal doxorubicin or pegylated liposomal doxorubicin alone).
• •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0- 1.
• •Subject has radiographically-documented measurable disease, as per RECIST 1.1 at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression).
• •Be able to receive IV dexamethasone or an equivalent IV corticosteroid.
• •Have all of the following:
• •hemoglobin ≥9 g/dL (without transfusion in the prior 7 days). Subjects may be enrolled into the study while receiving recombinant erythropoietin provide they have received recombinant erythropoietin for at least 4 weeks. before the first dose of study drug.
• •albumin \>25 g/L absolute neutrophil count (ANC) \>1,500/μL platelet count \>100,000/μL (without transfusion in the prior 7 days) either a serum creatinine \<=1.5 mg/dL or a calculated glomerular filtration rate \>60 mL/min/1.73 m2 (Cockcroft-Gault) CPK \<2.5 x upper limit of normal (ULN) Have total bilirubin \<xULN. If total bilirubin is \> 1,5xULN, measure direct and indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, subject may be eligible).
• •Have alkaline phosphatase (ALP) 2.5xULN; if the ALP is \>2.5xULN, then an ALP liver fraction or 5' nucleotidase must be \<ULN (as reported in absolute units of measure).
• •Have AST and ALT 2.5xULN. Have LVEF by MUGA scan or 2D-ECHO within normal limits for the institution.
• •Patients must be in postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically
• •Adequate recovery from acute toxicity of any prior treatment