The removal of plazma pegylated liposomal doxorubicin for the benefit of cytostatic therapy of patients with ovarian cancer.

Phase 1

• Conditions: Primary aim: enhanced therapeutic benefit of liposomal doxorubicin - a drug indicated for ovarian cancer resistant to chemotherapy with the first line drugs. This approach can be considered a model study for another formulation of liposomal drugs useful for cancer chemotherapy.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003324-36-CZ
• Lead Sponsor: Charles University in Prague, Faculty of Medicine in Hradec Králové

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-11
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Criteria for inclusion: 1 / Histologically confirmed epithelial ovarian cancer, fallopian tube or peritoneal carcinoma, 2 / Previous chemotherapy containing platinum and paclitaxel with the rise of resistance to chemotherapy; 3/Progression of disease (clinical findings, imaging techniques - CT, PET-CT MR elevation of tumor marker CA125) 4 / Age 18 years 5 / Performance status = 1, 6 / Life expectancy 12 weeks, 7 / Adequate hematopoietic, hepatic and renal function; 8 / Signed informed consent.
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

Criteria for exclusion: 1 / Pregnancy and lactation, 2 / Allergy to doxorubicin and other anthracyclines, 3 / Severe cardiac disease (arrhythmia, cardiac insufficiency, status post myocardial infarction), 4 / Prior treatment with anthracyclines up to the maximum cumulative dose (550mg / m2), 5 / significant persistent myelosuppression induced by previous treatment with cytotoxic agents, 6 / Generalized infection 7 / Severe impairment of liver function.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified