An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer

Study Overview
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Brief Summary
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This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.

Official Title
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A Non-interventional, Multicenter Study of the Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Trabectedin + PLD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 Histologically proven epithelial ovarian cancer ECOG 0-1 Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication Prior treatment with 1 or more chemotherapy regimen Exclusion Criteria: Platinum resistant disease: PFI < 6 months (progression within six months after first-line platinum-based chemotherapy) Unwilling or unable to have a central venous catheter Patients with hepatic impairment (Patients with elevated bilirubin) Patients with renal impairment (Patients with serum creatinine >1.5 mg/dL) Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3) Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex) AIDS-related Kaposi's sarcoma Lactation or pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trabectedin + PLD<br>Trabectedin + PLD according to SmPC | Drug: Trabectedin + PLD<br>* Combination of Trabectedin + PLD: PLD 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1). | Patient will be followed during 37 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS is defined as the time from the 1st treatment cycle until objective tumor progression or death | Patient will be followed during 37 weeks | 
| Safety according to CTCAE v4.0 | To assess patient safety and the tolerance of trabectedin + PLD | Patient will be followed during 37 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, trabectedin, recurrent ovarian cancer