EUCTR2006-004088-77-DEActive, not recruitingNot Applicable
Doxorubicin-Transdrug® in Advanced HepatoCellular CarcinomaA Randomized, Multicenter Phase 2-3 Study. - DOTAHCC1
BioAlliance Pharma0 sites210 target enrollmentStarted: August 16, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 210
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •18 to 80 years;
- •Patients with hepatocellular carcinoma (HCC), diagnosed according to AASLD guidelines;
- •Multinodular HCC regardless of the number of lesions, but with extension < 50% of the liver parenchyma;
- •Child-Pugh stage A ;
- •Left ventricular ejection fraction (LVEF) = 50% as determine by echocardiograph;
- •Adequate pulmonary function as measured by :
- •-a vital capacity (VC) > 70% of the theoretical
- •-a total lung capacity > 70% of the theoretical
- •-a carbon monoxide diffusing capacity (DLCO) > 70% of the theoretical and a DLCO/VA > 70% of the theoretical
- •-a forced expiratory volume in first second (FEV1)/ VC > 60%
- •-a SaO2 > 92%;
- •Platelets = 75 x 109 L;
- •Absolute neutrophil count = 1,0 x 109 L;
- •AST and/or ALT = 5 times upper limit of normal (NCI/CTC Grade 0, 1, 2);
- •Prothrombin activity > 60% and V factor > 60%;
- •ECOG score 0 - 2;
- •Patients who have signed and dated written informed consent;
- •Completed a period of at least 30 days since ending investigational device or drug trial;
- •Women of childbearing potential should have highly effective contraception method (hormonal contraception, implantable contraceptive, injectable contraceptive double-barrier method or intrauterine device) required over 3 months prior and throughout the entire duration of the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Troncular or supra-hepatic vein thrombosis;
- •Right and left lobar portal thrombosis;
- •Risk for variceal bleeding diagnosed on a gastro-duodenal fibroscopy performed at least one year before enrolment and characterized by:
- •-Large esophageal varices or isolated cluster of varices in fundus of stomach
- •-Red wale marks (longitudinal red streaks on varices)
- •-Cherry-red spots (red, discrete, flat spots on varices)
- •-Hematocystic spots (red, discrete, raised spots)
- •-Diffuse erythema;
- •HCC developed on a transplanted liver;
- •Presence of extra-hepatic metastases;
- •Patients able to benefit from a hepatic transplantation, surgical resection, percutaneous ethanol injection or radiofrequency ablation;
- •Prior systemic chemotherapy, TACE, embolisation, radiation therapy for HCC regardless of the time elapsed before the enrolment;
- •Patient having undergone a 450mg/m² cumulated dose of doxorubicin;
- •Patients who has benefited from a surgical resection or percutaneous treatment in the month preceding the enrolment;
- •Patient currently being treated by an immunosuppressor agent that cannot be stopped;
- •Patient treated by an anticoagulant that cannot be stopped;
- •Patient with unstable and developing medical-surgical problems;
- •Presence of cardiac insufficiency, ongoing coronaropathy, arrhythmia or conduction disorders on the electrocardiogram;
- •Patient with a life expectancy of less than 3 months;
- •Pregnant or breast-feeding women;
- •Patients with a mental deficiency preventing proper understanding of trial protocol requirements;
- •Prior entry into this study.
Investigators
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