Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Sorafenib (Nexavar, BAY43-9006); Erlotinib (Tarceva); Placebo
Intervention description: Sorafenib 400 mg twice daily; Erlotinib 150 mg once daily; Matching erlotinib placebo 150 mg once daily
Intervention MeSH terms: Erlotinib Hydrochloride; Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 732.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sorafenib (Nexavar); Erlotinib (Tarceva); First Line; HCC

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.
    

Eligibility criteria:

        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)