Comparison of Quality of Life (QoL) Between Trabectedin/PLD and Standard Platinum-based Therapy in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer

• Women aged ≥ 18 years

• Patients with histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer who received ≥1 prior chemotherapy

• Patients must be eligible for platin-containing therapy; Patient is defined as platin-sensitive when considered for platin-containing therapy by the investigator. The time frame from end of prior therapy until disease progression alone is not pivotal for study participation. Patients without a platin-containing regimen in the previous line who are also eligible for platin-containing regime are also appropriate for participation

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

• Adequate baseline organ function as defined as

‣ Leucocytes \> 3.0 x 109/l

⁃ Platelet count \> 100 x 109/l

⁃ Absolute neutrophil count (ANC) ≥1500/mm3

⁃ Haemoglobin ≥ 9 g/dl

⁃ Alkaline Phosphatase (AP) ≤ 2.5 × ULN (consider hepatic isoenzymes 5 nucleotidase or gamma glutamyl transpeptidase (GGT), if the elevation could be osseous in origin)

⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN

⁃ Creatinine-Clearance ≥ 60 ml/min (MDRD formula or Cockroft \& Gault formula)

⁃ Serum creatinine ≤ 1.5 mg/dl

⁃ Creatine phosphokinase (CPK) ≤ 2.5 × ULN

⁃ Total bilirubin \< ULN

• Women of childbearing potential should use contraceptives or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication or be surgically sterile.

• Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiogram

• Patients must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures.