Resumen

The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

Descripción detallada

The following abbreviations were used in the Adverse Event section: * international normalized ratio (inr) * Common Terminology Criteria for Adverse Events (ctcae) * Not Otherwise Specified (nos) * Gastrointestinal (gi) * Central nervous system (cns) * Absolute Neutrophil Count (anc) * Alanine aminotransferase (ALT) * Aspartate aminotransferase (AST) * Creatine phosphokinase (cpk) * Gammaglutamyltransferase (ggt) * Genitourinary (gu) * Atrioventricular (av)

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Ages eligible for study: 18 years and above, Genders eligible for study: both
Patients who have a life expectancy of at least 12 weeks
Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC)
Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (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, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]). Any cancer curatively treated \> 3 years prior to entry is permitted
Renal failure requiring hemo- or peritoneal dialysis
History of cardiac disease
Active clinically serious infections
Known history of human immunodeficiency virus (HIV) infection
Known central nervous system tumors including metastatic brain disease
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Intervenciones

drug

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.

drug

Placebo

Sorafenib-matching placebo tablets were orally administered twice daily (bid).

Ubicaciones

Mar del Plata, Buenos Aires, Argentina

Pilar, Buenos Aires, Argentina

Bueno Aires, Ciudad Auton. de Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma