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

• Conditions: Ovarian Cancer
• Interventions: Drug: Trabectedin + PLD

• Registration Number: NCT03446495
• Lead Sponsor: Suriya Yessentayeva

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-28
• Status Verified: 2018-02
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-23
• Last Update Submitted: 2018-02-23
• Study First Posted: 2018-02-26
• Last Update Posted: 2018-02-26
• Primary Completion: 2019-03-20
• Study Completion: 2019-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trabectedin + PLD	Trabectedin + PLD	Trabectedin + PLD according to SmPC

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Patient will be followed during 37 weeks	ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1).

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Almaty regional oncological dispensary; 🇰🇿 Almaty, Kazakhstan

West Kazakhstan regional oncology dispensary; 🇰🇿 Oral, Kazakhstan

Almaty oncological center; 🇰🇿 Almaty, Kazakhstan

Kazakh institute of oncology and radiology; 🇰🇿 Almaty, Kazakhstan

Astana Oncology Center; 🇰🇿 Astana, Kazakhstan

Kyzylorda regional Oncological center; 🇰🇿 Kyzylorda, Kazakhstan

North Kazakhstan Regional Oncology Center; 🇰🇿 Petropavlovsk, Kazakhstan

East Kazakhstan Regional Oncology Dispensary; 🇰🇿 Ust-Kamenogorsk, Kazakhstan

South Kazakhstan regional oncologic dispensary; 🇰🇿 Shymkent, Kazakhstan