Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer

Inclusion Criteria:

1. Females aged ≥ 18 years at time of signing informed consent form.
2. Histologically proven diagnosis of cancer of the ovary, the fallopian tube or primaryperitoneal cancer.
3. Measurable or non-measurable disease (according RECIST v1.1) or CA-125 assessabledisease (according GCIG criteria) or histologically proven diagnosis of relapse.
4. Platinum-treatment free interval (TFIp) > 6 months prior to cycle 1 day 1 ofreinduction therapy.
5. Disease stabilization without remission or progression ac-cording to RECIST or GCIGcriteria after three cycles of platinum-based chemotherapy for recurrent disease.
6. Symptomatic disease at time of baseline abdominal/GI symptom scale score >15 (EORTCQLQ-OV28)
7. Completion of EORTC QLQ-OV28 at Baseline within 7 days prior to treatment start.
8. Patients should have received previously a taxane derivative.
9. ECOG performance status ≤ 2.
10. Life expectancy of at least 12 weeks.
11. Adequate bone marrow, renal and hepatic function defined as:

• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
• Platelet count ≥ 100 x 10^9/L
• Hemoglobin ≥ 9.0 g/dL
• Serum creatinine ≤1.5 mg/dL (≤ 132.6 µmol/L) or creatinine clearance ≥ 60 mL/min
• Creatine phosphokinase (CPK) ≤ 2.5 x ULN
• Serum aspartate aminotransferase (AST, SGOT) or alanine aminotransferase (ALT,SGPT) ≤ 2.5 x ULN (≤ 5 x ULN in the presence of liver metastases)
• Alkaline phosphatase (ALP) ≤ 2.5 ULN
• Serum bilirubin ≤ ULN
• Albumin ≥ 25 g/l

12. Participation in an informed consent discussion with the appropriate trial-relatedhealth care representative, full understanding of the implications and constraints ofthe protocol, and provision of written informed consent prior to the commencement ofthe trial-related procedures.
13. Geographically accessibility for treatment and follow-up.
14. For women of childbearing potential (WOCBP): agreement to remain abstinent (refrainfrom heterosexual inter-course) or use a contraceptive method with a failure rate of < 1 per-centage per year during the treatment period and for at least six months afteradministration of the last dose of chemo-therapy. A woman is considered to be ofchildbearing po-tential if she is postmenarcheal, has not reached a post-menopausalstate (≥ 12 continuous months of amenorrhea with no identified cause other thanmenopause), and has not undergone surgical sterilization (removal of ovaries,fal-lopian tubes, and/or uterus). Examples of contraceptive methods with a failurerate of < 1 percentage per year in-clude but are not limited to bilateral tuballigation and/or oc-clusion, male sterilization, and intrauterine devices, and nor-maland low dose combined oral pill plus male condom or Cerazette (desogestrel) plus malecondom. Cerazette is currently the only highly efficacious progesterone based pill.The reliability of sexual abstinence should be evaluated in relation to the durationof the clinical trial and the preferred and usual lifestyle of the patient. Periodicabstinence (e.g., calendar, ovulation, symptothermal, or postovulation meth-ods) andwithdrawal are not acceptable methods of contra-ception.

Exclusion Criteria:

1. Ovarian tumors of low malignant potential (e.g. borderline tumors).
2. Non-epithelial ovarian or mixed epithelial/non epithelial tumors (e.g. mixed Mülleriantumors).
3. Patients with an objective response in terms of a partial or complete remission oralternatively progressive disease ac-cording to RECIST or GCIG criteria after threecycles of platinum-based reinduction chemotherapy.
4. Patients who have received previous radiotherapy for ovarian cancer.
5. History of congestive heart failure (NYHA classification > 2, even if medicallycon-trolled).
6. History of myocardial infarction within the last six months (documented or byelectrocardiogram).
7. History of atrial or ventricular arrhythmias.
8. Impaired liver function, hyperbilirubinemia, Serum creatinine >1.5 mg/dL or > 132.6 μmol/L or creatinine clearance < 60 mL/min, left ventricular ejection fraction < 45 %.
9. Severe active or uncontrolled infection.
10. Concurrent severe medical problems unrelated to malignancy, which would significantlylimit full compliance with the trial or expose the patient to extreme risk ordecreased life expectancy.
11. Patients with known hypersensitivity to the active substance or their compoundsrelated to trabectedin or PLD and patients with known hypersensitivity to one ofactive substances or one of their compounds used in platinum-based chemotherapy asdescribed in the Summaries of Medicinal Products.
12. Patients with potential risks according to contraindication, warnings or interactionsof the used chemotherapeutic agents as stated in the SmPCs are not eligible forparticipation in this trial.
13. Patients with contraindication regarding CT or MRI (only in case of contrast allergy)are excluded.
14. Women of childbearing potential (WOCBP) not using highly effective contraceptivemethods.
15. Pregnancy or breast-feeding.