Status:
COMPLETED
Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
University of Chicago
Conditions:
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 che...
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 p...
Eligibility Criteria
Inclusion
- Mesothelioma that has been previously treated with at least one chemotherapy regimen
- 18 years of age or older
- Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities
- Four or more weeks since last major surgery
- Four or more weeks since last radiation therapy
- Three or more weeks since last chemotherapy
- Life expectancy of 12 weeks or more
- Blood tests that show kidneys, liver and bone marrow to be working adequately
- Able to comply with study and/or follow-up procedures
Exclusion
- Prior exposure to Tarceva (OSI-774, erlotinib), trastuzumab, ZD1839 or C225
- Receiving anticoagulation medication other than low dose Coumadin
- Clinically significant heart disease such as uncontrolled hypertension, previous heart attack within past 12 months, uneven heartbeat, etc.
- History of central nervous system disease such as seizures not controlled with standard medical therapy, brain metastases or history of stroke
- Major surgery within 28 days of screening
- Daily treatment with aspirin or anti-inflammatory medications
- Pregnant or lactating (pertaining to women only)
- Serious or nonhealing wound, ulcer or bone fracture
- Difficulty swallowing
- A disease or disorder that interferes with ability to digest and absorb food
- History of coughing up more than 1/4 teaspoon of blood
- A medical condition that could make it unsafe for patient to participate in this study
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00137826
Start Date
February 1 2004
End Date
July 1 2009
Last Update
December 26 2011
Active Locations (3)
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1
The University of Chicago
Chicago, Illinois, United States, 60637
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115