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

Suriya Yessentayeva9 sites in 1 country60 target enrollmentMarch 28, 2017

ConditionsOvarian Cancer

InterventionsTrabectedin + PLD

DrugsTrabectedin + PLD

Overview

Phase: Not Applicable
Intervention: Trabectedin + PLD
Conditions: Ovarian Cancer
Sponsor: Suriya Yessentayeva
Enrollment: 60
Locations: 9
Primary Endpoint: Objective Response Rate (ORR)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 28, 2017

End Date

May 20, 2019

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Suriya Yessentayeva

Responsible Party

Sponsor Investigator

Principal Investigator

Suriya Yessentayeva

Chair

Scientific Medical Society, Kazakhstan

Eligibility Criteria

Inclusion Criteria

•Histologically proven epithelial ovarian cancer
•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