A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

CompletadoFase 2ClinicalTrials.gov

ID: NCT00108953Tipo: INTERVENTIONALInicio: 1 de abr de 2005Fin estimado: 1 de abr de 2008

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

Descripción detallada

In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations. The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints. The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients who have a life expectancy of at least 12 weeks
Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
Patients must have at least one tumor lesion that meets both of the following criteria:
can be accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
has not been previously treated with local therapy
Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Criterios de exclusión

Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted
History of cardiac disease
Serious myocardial dysfunction
Active, clinically serious infections
Known history of Human Immunodeficiency Virus (HIV) infection
Known Central Nervous System (CNS) tumors including metastatic brain disease
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Intervenciones

drug

Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin

Multi kinase inhibitor plus Chemotherapy

drug

Doxorubicin/Placebo

Chemotherapy plus Placebo

Ubicaciones

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Neuquén, Neuquén Province, Argentina

Buenos Aires, Argentina

Patrocinadores

PrincipalBayer

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