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

Sponsor
Hoffmann-La Roche
Study ID
NCT00605722
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jan 31, 2008
Start date
Mar 31, 2008
Status verified
Jun 2014
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab + erlotinib
    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.

Primary Outcome Measure

Percentage of Participants With Progression-free Survival (PFS) [ Time Frame: Week 16 ]

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