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.
Conditions
Interventions
Trade Name: Caelyx
Product Name: CAELYX CARTON 20 mg/10 ml
Product Code: EU/1/96/011/001
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Charles University in Prague, Faculty of Medicine in Hradec Králové
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective to be solved in this project is the issue of circulation of nanotechnologically modified anticancer drugs in the time when they have no effect and may be the source of adverse side-effects and thus influence significantly both the treatment efficacy and „benefit cost“. After Cmax is achieved in the tumour tissue further circulation of liposomal cytostatic drug is not effective. Plasma level leads only to the development of adverse efects but with no effect. With a suitable extracorporeal elimination system it is possible markedly limit acute toxic effects of chemotherapy. For the therapy with rheohemapheresis we suggest to use pegylated liposomal doxorubicine in female patients with ovarian cancer. Newly, we wish to monitore still unexplored changes of hematologic, immunologic and metabolic parameters. The proposed project is in consistence with the program of the Ministry of Health, Czech Republic - 03. Oncology. ;Secondary Objective: Secondary aim: identification of pathologic factors (covariates), that might significantly modify the liposomal doxorubicin kinetics and therapeutic effectiveness of such chemotherapy (age, progression of tumours with hepatic metastases,and others). The project is compatible with principles and priorities of Resort program RPV III. chapter 7. 03, confined to oncology. Priority: “Combination of molecular-directed therapy with classical approach (chemotherapy)“ and Contributions: “Improved medical care of patients suffering from cancers“.;Primary end point(s): Estimation of individual doxorubicin kinetics (cycle 1): to determine doxorubicin plasma concentration after the first doxorubicin i.v. dose, 2 ml will be taken from a venous blood. In respect to both the clearance of doxorubicin and RHP, the first postinfusion sample will be drawn at 30 min after the termination of the first infusion. Additional samples will be taken at 44, 46, 72 a 150 postinfusion hours. Doxorubicin plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical and pathological response to therapy. Patients will be followed during therapy and for 1 year after the completion of therapy (follow-up period) using physical examination, ultrasonography, RTG, computed tomographic (CT) scanning CT and /or MR), tumor biomarker titration (CA 125) and residual illness evaluation graded according to WHO classification - remission (no sign of tumor progression), partial remission (50% decrease in tumour size), tumour persistence (no change). TNM classification will be used as well (Sobin and Witekind, 1997). ;Timepoint(s) of evaluation of this end point: In the years 2013 - 2014: patients will be planned to be enrolled in respect to eligibility criteria, cyclus 1-4 and 2015: the termination of data collection and final evaluation including that based on statistical methodology. The outcome will be presented and published as a paper in an international medical journal. | — |
Countries
Czech Republic
Contacts
Public ContactStanislav Filip
Department of Oncology and Radiotherapy, Charles University in Prague, University Hospital in Hradec Králové
Outcome results
None listed