None listed
Conditions
Interventions
Group 1 Type of group
Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
Group name:Group 2 Type of group
Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
Sponsors
BAYER HEALTHCARE AG,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female patients> 18 years of age. • Patients with a life expectancy of at least 12 weeks. • Patients with HCC documented by histological or cytological means (the original biopsy documentation for diagnosis is acceptable if tumor tissue is not available) or clinical diagnosis according to the AASLD criteria (see Annex 10.9) in patients with cirrhosis. Histological confirmation is mandatory in patients without cirrhosis. • Patients must have at least one tumor lesion that meets the following criteria: The lesion can be accurately measured in at least one dimension according to the RECIST criteria. The lesion has been previously treated with local treatment (such as surgery, radiotherapy, chemoembolization liver arterial therapy, radiofrequency ablation, percutaneous ethanol injection or cryoablation). • Patients who have received local treatment such as surgery, radiotherapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation may be admitted to the study. Previously treated lesions will not be selected as target lesions. The local treatment must have been completed at least 4 weeks before the baseline examination. • Patients with a functional ECOG PS status of 0 or 1 (Annex 10.3). • Child-Pugh Cirrhosis A. Child-Pugh status will be calculated from clinical findings and laboratory results during the selection period. • Resolution of all acute side effects of any previous local treatment up to a degree <1, according to the common criteria of toxicity of adverse events (CTCAE) of the National Cancer Institute (NCI) , version 3.0. • Patients who give informed written consent before any specific evaluation procedure of the study, understanding that the patient has the right to leave the study at any time.
Exclusion criteria
Exclusion criteria: • Renal failure requiring hemo- or peritoneal dialysis • Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) – related illness or serious acute or chronic illness. • Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren’s syndrome) including congenital abnormality (e.g. Fuch’s dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test). • Child-Pugh class B or C • Previous treatment with yttrium- 90 spheres • Clinically significant peripheral vascular disease • History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted. (See Appendix 10.7) • History of interstitial lung disease (ILD) • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry • Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), except HBV/HCV infections • Uncontrolled ascites (defined as not easily controlled with diuretic treatment) • Pregnant or breast-feeding patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Measure:Overall Survival Timepoints:Desde la aleatorizacion del primer paciente hasta los 34 meses o la fecha de fallecimiento de cualquier causa, lo que ocurra primero | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD. Measure:Time to Radiological Tumor Progression (TTP) Timepoints:From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ; Outcome name:Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD. Measure:Disease Control Timepoints:From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks ; Outcome name:The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 no problems; 2 some problems; 3 extreme problems). The 5 health dimensions are summariz | — |
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Greece, Hong Kong, Israel, Italy, Korea North, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Taiwan, United Kindgdom, United States
Contacts
Public ContactLuis Razzeto
BAYER S.A.
Outcome results
None listed