Therapy of ovarian carcinoma with doxorubicin using plasmafiltration

Liposoms (drug delivery systems) in kinetically guided therapy of ovarian platinum-resistant carcinoma with doxorubicin using plasmafiltration - Kinetically therapy of ovarian platinum-resistant carcinoma with doxorubicin using plasmafiltration

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000971-26-CZ

Enrollment

Registered

2016-04-04

Start date

2016-04-04

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Chemotherapy of ovarian platinum-resistant carcinoma

Interventions

Trade Name: CAELYX Product Name: Caelyx Product Code: EU/1/96/011/001 Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged between 18 and 60 years. (In consideration of the economic demands, it is not possible to collect a larger group of patients. Nevertheless, in spite of this, it will be possible to achieve significant results of PF effectivity.) Histologically confirmed epithelial ovarian cancer, that of fallopian tube or peritoneal carcinomas. Disease progression (based on clinical signs and symptoms using imaging methods — CT, PET-CT, MR). Tumor marker CA125 elevation. Signed informed consent. Performance state = 1.6. Life expectancy = 12 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Severe heart disease, serious hepatic and/or renal dysfunction. Significant myelosuppression induced by previous treatment with cytotoxic agents. Pregnancy and/or lactation. Serious infections.

Design outcomes

Primary

Measure	Time frame
Main Objective: Our primary aim is to demonstrate that the safety and efficiency of extracorporeal elimination (plasmafiltration) of pegylated liposomal doxorubicin (PLD) is dependent on its kinetically guided regulation i.e. extracorporeal removal should be individualized according to the patient´s elimination capacity.;Secondary Objective: Our secondary aim is the detailed monitoring of therapeutic response and PLD toxicities.;Primary end point(s): Progression of disease ;Timepoint(s) of evaluation of this end point: 1 month	—

Measure

Time frame

Main Objective: Our primary aim is to demonstrate that the safety and efficiency of extracorporeal elimination (plasmafiltration) of pegylated liposomal doxorubicin (PLD) is dependent on its kinetically guided regulation i.e. extracorporeal removal should be individualized according to the patient´s elimination capacity.;Secondary Objective: Our secondary aim is the detailed monitoring of therapeutic response and PLD toxicities.;Primary end point(s): Progression of disease ;Timepoint(s) of evaluation of this end point: 1 month

—

Secondary

Measure	Time frame
Secondary end point(s): Febrile neutropenia according to WHO clasification IV. Throbocytopenia (III.-IV) associated with bleeding Anemia (III.-IV.) associated with anemic syndrome or pancytopenia (III.-IV.) Hand-foot syndrome according to WHO clasification III.-IV.;Timepoint(s) of evaluation of this end point: more than 10 days	—

Countries

Czech Republic

Contacts

Public ContactMedical Faculty in Hradec Králové

Charle University in Prague, Medical Faculty

granty@lfhk.cuni.cz+420495816136

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026