Overview

This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatments sorafenib (nexavar, bay43-9006), sorafenib (nexavar, bay43-9006) + erlotinib, tarceva
Phase phase 3
Sponsor Bayer
Start date May 2009
End date April 2012
Trial size 732 participants
Trial identifier NCT00901901, 12917, 2008-006021-14

Summary

This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
sorafenib (nexavar, bay43-9006)
Sorafenib 400 mg twice daily + matching erlotinib placebo daily
(Active Comparator)
Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
sorafenib (nexavar, bay43-9006) + erlotinib, tarceva
Sorafenib 400 mg twice daily + erlotinib 150 mg daily

Primary Outcomes

Measure
Overall Survival
time frame: From randomization of the first patient until 34 months or date of death of any cause whichever came first

Secondary Outcomes

Measure
Time to Radiological Tumor Progression (TTP)
time frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Disease Control
time frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index
time frame: The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS
time frame: The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients > 18 years of age - Patients who have a life expectancy of at least 12 weeks - Patients with histological or cytologically documented HCC - Patients must have at least one tumor lesion that meets both of the following criteria: - The lesion can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (RECIST) - The lesion has not been previously treated with local therapy - Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1 - Cirrhotic status of Child-Pugh class A. - Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time. Exclusion Criteria: - 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. - 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). - History of interstitial lung disease (ILD). - Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. - Previous treatment with yttrium-90 spheres - Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. - Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

Additional Information

Official title A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
Description European quality of life scale (5 dimensions) (EQ-5D)
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Bayer.