Clinical trial NCT03446495: An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: ovarian cancer, trabectedin, recurrent ovarian cancer
Lead sponsor: Scientific Medical Society, Kazakhstan
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2018-02-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Patient will be followed during 37 weeks
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Patient will be followed during 37 weeks
measure: Safety according to CTCAE v4.0
timeFrame: Patient will be followed during 37 weeks
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Almaty oncological center
city: Almaty
country: Kazakhstan
facility: Almaty regional oncological dispensary
city: Almaty
country: Kazakhstan
facility: Kazakh institute of oncology and radiology
city: Almaty
country: Kazakhstan
facility: Kazakh institute of oncology and radiology
city: Astana
country: Kazakhstan
facility: Astana Oncology Center
city: Kyzylorda
country: Kazakhstan
facility: Kyzylorda regional Oncological center
city: Oral
country: Kazakhstan
facility: West Kazakhstan regional oncology dispensary
city: Petropavlovsk
country: Kazakhstan
facility: North Kazakhstan Regional Oncology Center
city: Shymkent
country: Kazakhstan
facility: South Kazakhstan regional oncologic dispensary
city: Ust-Kamenogorsk
country: Kazakhstan
facility: East Kazakhstan Regional Oncology Dispensary
Study officials:
References: