Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
|ClinicalTrials.gov Identifier: NCT00137826|
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : December 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: Erlotinib Drug: Bevacizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||July 2009|
- Drug: Erlotinib
Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.Other Names:
- Drug: Bevacizumab
Given intravenously over 30-90 minutes, on day 1 of each 21-day cycle. Participants may continue on study treatment until disease progresses or they experience serious side effects.Other Name: Avastin
- To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma [ Time Frame: 3 years ]
- To determine the time to tumor progression
- to determine the duration of response
- to determine the median and overall survival of patients
- to determine the safety of the drugs administered [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137826
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Pasi A Janne, MD, PhD||Dana-Farber Cancer Institute|