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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03446495

Acronym

Renaissance

Enrollment

Registered

2018-02-26

Start date

2017-03-28

Completion date

2019-05-20

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

ovarian cancer, trabectedin, recurrent ovarian cancer

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.

Interventions

DRUGTrabectedin + PLD

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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Kazakhstan

Contacts

Primary ContactSuriya Yessentaeva, PhD

surya_esentay@mail.ru+77077942910

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026