Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Massachusetts General Hospital; University of Chicago
• Treatments: Bevacizumab; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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