A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.

A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer

This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated time on study treatment was until disease progression, and the target sample size was <100 individuals.

Inclusion Criteria:

• adult patients, ≥ 18 years of age;
• advanced or metastatic liver cancer;
• ≥ 1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment.

Exclusion Criteria:

• prior or concomitant systemic anti-cancer treatment for advanced disease;
• patients at high risk of variceal bleeding;
• clinically significant cardiovascular disease;
• major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.