An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
NCT ID: NCT03446495
Last Updated: 2018-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2017-03-28
2019-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Trabectedin + PLD
Trabectedin + PLD according to SmPC
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Johnson & Johnson
INDUSTRY
Suriya Yessentayeva
OTHER
Responsible Party
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Suriya Yessentayeva
Chair
Locations
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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
Petropavl, , Kazakhstan
South Kazakhstan regional oncologic dispensary
Shymkent, , Kazakhstan
East Kazakhstan Regional Oncology Dispensary
Ust-Kamenogorsk, , Kazakhstan
Countries
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Central Contacts
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Facility Contacts
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Mukhtar Tuleutaev, PhD
Role: primary
Esengeldy Rabaev, PhD
Role: primary
Other Identifiers
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R279741OVC4001
Identifier Type: -
Identifier Source: org_study_id
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