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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
Secondary Outcome
To determine the time to tumor progression
Condition
Mesothelioma
Intervention
Erlotinib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
37
Start Date
February 2004
Completion Date
July 2009
Primary Completion Date
March 2007
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pasi A Janne, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00137826
Organization ID
03-369
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital
Study Sponsor
Pasi A Janne, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
December 2011