Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
The purpose of this study is to determine whether the combination of the investigational drugs Avastin and Tarceva are effective in patients with mesothelioma who have previously been treated with chemotherapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma|
- To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To determine the time to tumor progression [ Time Frame: TBD ] [ Designated as safety issue: No ]
- to determine the duration of response [ Time Frame: TBD ] [ Designated as safety issue: No ]
- to determine the median and overall survival of patients [ Time Frame: TBD ] [ Designated as safety issue: No ]
- to determine the safety of the drugs administered [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2004|
|Study Completion Date:||July 2009|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
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.
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Pasi A Janne, MD, PhD||Dana-Farber Cancer Institute|