Trial on Trabectedin (ET-743) vs Clinician's Choice Chemotherapy in Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients

Inclusion Criteria

• •1. Female of age 18 years or older
• •2. Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
• •3. Platinum resistant or sensitive patients with either:
• •1. BRCA mutated patients
• •2. BRCAness phenotype patients: patients who have received and responded (subsequent PFI\>6 months) to at least 2 previous platinum based chemotherapy lines
• •3. Platinum sensitive patients who are not able to receive or not willing to receive other platinum treatments
• •4. Measurable and evaluable disease per RECIST 1.1(Subjects with isolated rising CA-125 without radiologically visible disease are excluded)
• •5. ECOG performance status 0 or 1
• •6. No limits in the number of previous chemotherapy lines, previous treatment with parp inhibitors is allowed
• •7. Left Ventricular Ejection Fraction (LVEF) ≥ institutional lower limit normal
• •8. Life expectancy of at least 3 months
• •9. Adequate organ functions:
• •1. Hematopoietic: Absolute neutrophil count ≥ 1,500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dl
• •2. Hepatic: AST and ALT ≤ 1.5 times upper limit of normal (ULN)\* ; Alkaline Phosphatase ≤ 2.5 times ULN\* ; Bilirubin ≤ 1.5 times ULN. NOTE: \* ≤ 3 times ULN if liver metastases are present
• •3. Renal: Creatinine Clearance ≥ 45 ml/min or Serum Creatinine ≤1.5 x ULN
• •4. Serum Albumin \>2.5 g/dl
• •10. No other invasive malignancy within the past 3 years except non-melanoma skin cancer or in situ cervical cancer (patients with previous cancers may be enrolled providing that no recurrences have be reported in the last 3 years)
• •11. Written Informed Consent
• •12. Adequately recovered from the acute toxicity of any prior treatment
• •13. For agents in the standard arm, also refer to the local prescribing information with regards to warnings, precautions, and contraindications