Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
18 Years
N/A
Both
Mesothelioma
Trial Information
Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Pasi A Janne, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
03-369
NCT ID:
NCT00137826
Start Date:
February 2004
Completion Date:
July 2009
Related Keywords:
- Mesothelioma
- Mesothelioma
- Avastin
- Bevacizumab
- Tarceva
- OSI-774
- Erlotinib
- Mesothelioma
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| The University of Chicago | Chicago, Illinois 60637 |
