Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma

This is a randomised 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.

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)

Conditions

• Hepatocellular carcinoma

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures 

• Overall survival measured via patient phone contacts after treatment is complete
  [ Time Frame: From the date of randomisation until th date of death due to any cause ]
  [ Designated as safety issue: No ]

Secondary outcome measures

• Time to Progression, response rate, duration of response, disease control rate determined by tumour measurement using MRI or CT scans
  [ Time Frame: Every 6 weeks during treatment ]
  [ Designated as safety issue: No ]
• Health Related Quality of Life and Utility Values as measured by the EQ-5D
  [ Time Frame: Every 6 weeks during treatment ]
  [ Designated as safety issue: No ]
• Laboratory testing
  [ Time Frame: Every 3 weeks during treatment ]
  [ Designated as safety issue: Yes ]
• AE reporting
  [ Time Frame: Every 3 weeks during treatment ]
  [ Designated as safety issue: Yes ]
• ECG
  [ Time Frame: At the start and at the completion of treatment ]
  [ Designated as safety issue: Yes ]
• Vital signs
  [ Time Frame: Every 3 weeks during treatment ]
  [ Designated as safety issue: Yes ]

Study arms and assigned interventions

1. Active comparator
   • Drug: Sorafenib (Nexavar, BAY43-9006)
     Sorafenib 400 mg BID + Matching Erlotinib Placebo QD
2. Active comparator
   • Drug: Sorafenib (Nexavar, BAY43-9006) + Erlotinib, Tarceva
     Sorafenib 400 mg BID + Erlotinib 150 mg QD

Study Start

May 2009 – July 2011

Eligibility & Criteria

• Ages eligible for study: 18 years and older
• Genders eligible for study: Both
• Accepts healthy volunteers: No

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 RECIST
  • The lesion has not been previously treated with local therapy
• Patients who have an ECOG PS 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).

Total Enrolment

700

Contact Details

Bayer Clinical Trials 
clinical-trials-contact@bayerhealthcare.com
For trial location information (Phone Menu Options ‘3’ or ‘4’) (+)1-888-84 22937