Status:
UNKNOWN
An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
Lead Sponsor:
Suriya Yessentayeva
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 20 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03446495
Start Date
March 28 2017
End Date
May 20 2019
Last Update
February 26 2018
Active Locations (10)
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1
Almaty oncological center
Almaty, Kazakhstan
2
Almaty regional oncological dispensary
Almaty, Kazakhstan
3
Kazakh institute of oncology and radiology
Almaty, Kazakhstan
4
Kazakh institute of oncology and radiology
Almaty, Kazakhstan