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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00137826 |
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Date of registration:
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29/08/2005 |
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Primary sponsor: |
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Public title:
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Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
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Scientific title:
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Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00137826 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Pasi A Janne, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dana-Farber Cancer Institute |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mesothelioma
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Intervention(s)
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Drug: Bevacizumab
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Drug: Erlotinib
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Primary Outcome(s)
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To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
[Time Frame: 3 years]
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Secondary Outcome(s)
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to determine the duration of response
[Time Frame: TBD]
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to determine the median and overall survival of patients
[Time Frame: TBD]
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to determine the safety of the drugs administered
[Time Frame: 3 years]
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To determine the time to tumor progression
[Time Frame: TBD]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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