Therapy of ovarian carcinoma with doxorubicin using plasmafiltratio

Phase 1

Conditions: Chemotherapy of ovarian platinum-resistant carcinoma
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-000971-26-CZ

Lead Sponsor: Charles University in Prague, Medical Faculty

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>;Timepoint(s) of evaluation of this end point: 1 month

Secondary Outcome Measures

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