Trial information
A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
Status: Recruiting
Protocol number: ML21213
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
Brief summary: This single arm study will evaluate the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients will be treated with Tarceva 150mg po daily plus Avastin 5mg/kg i.v. every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 49.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Liver Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Progression-free survival Time frame: Week 16
Key secondary outcomes: 1. Overall response rate, disease control rate, time to tumor progression, progression-free survival, overall survival. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2008
Trial registration date: 01/21/2008
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
Philippines
Taiwan
- Kaohsiung
- Kueishan
- Tainan
- Taipei
