Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
Each cycle of study treatment lasts 21 days. The patient will take erlotinib by mouth once
daily. On day 1 of every cycle, the patient will receive bevacizumab intravenously over a
30-90 minute time period.
CT scan(s), MRI(s) and/or x-ray(s) of the cancer site will be performed every 6 weeks (2
cycles) to assess the extent of the response to treatment.
Bloodwork will be performed before the first dose of erlotinib and bevacizumab at Cycle 1,
Cycle 2, Cycle 3, and at the end of treatment.
At the completion of the treatment a physical exam, vital signs, blood tests, urine tests
and standard radiologic testing will be performed.
The duration of study depends upon how the patients' mesothelioma responds to treatment as
well as how well the patient tolerates the medication.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
Pasi A Janne, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|The University of Chicago||Chicago, Illinois 60637|