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| Descriptive Information Fields | |||||
| Brief Title † | Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma | ||||
| Official Title † | Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | 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 ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Mesothelioma | ||||
| Intervention † | Drug: Erlotinib Drug: Bevacizumab |
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| MEDLINE PMIDs | 16014882, 15310767 | ||||
| Links | Dana-Farber Cancer Institute Lowe Thoracic Oncology Program ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 37 | ||||
| Start Date † | February 2004 | ||||
| Completion Date | March 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00137826 | ||||
| Organization ID | 03-369 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Dana-Farber Cancer Institute | ||||
| Collaborators †† | Massachusetts General Hospital University of Chicago |
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| Investigators † |
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| Information Provided By | Dana-Farber Cancer Institute | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | August 29, 2005 | ||||
| Last Updated Date | December 20, 2007 | ||||