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

Roche

Status and phase: Completed; Phase 2

Conditions: Liver Cancer

Treatments: Drug: erlotinib (Tarceva); Drug: bevacizumab (Avastin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605722

ML21213

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

bevacizumab + erlotinib

Experimental group

Description:

Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.

Treatment:

Drug: bevacizumab (Avastin)

Drug: erlotinib (Tarceva)