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

Ovarian Cancer Clinical Trial

— Renaissance  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03446495
• Other study ID #: R279741OVC4001
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2018
• Last updated: February 23, 2018
• Start date: March 28, 2017
• Est. completion date: May 20, 2019

Study information

• Verified date: February 2018
• Source: Scientific Medical Society, Kazakhstan
• Contact: Suriya Yessentaeva, PhD
• Phone: +77077942910
• Email: surya_esentay[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Trabectedin + 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.

Locations

Country	Name	City	State
Kazakhstan	Almaty oncological center	Almaty
Kazakhstan	Almaty regional oncological dispensary	Almaty
Kazakhstan	Kazakh institute of oncology and radiology	Almaty
Kazakhstan	Kazakh institute of oncology and radiology	Almaty
Kazakhstan	Astana Oncology Center	Astana
Kazakhstan	Kyzylorda regional Oncological center	Kyzylorda
Kazakhstan	West Kazakhstan regional oncology dispensary	Oral
Kazakhstan	North Kazakhstan Regional Oncology Center	Petropavlovsk
Kazakhstan	South Kazakhstan regional oncologic dispensary	Shymkent
Kazakhstan	East Kazakhstan Regional Oncology Dispensary	Ust-Kamenogorsk

Sponsors (2)

Lead Sponsor	Collaborator
Suriya Yessentayeva	Johnson & Johnson

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Safety according to CTCAE v4.0	To assess patient safety and the tolerance of trabectedin + PLD	Patient will be followed during 37 weeks