Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
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ClinicalTrials.gov Identifier: NCT00137826 |
Recruitment Status
:
Completed
First Posted
: August 30, 2005
Last Update Posted
: December 26, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mesothelioma | Drug: Erlotinib Drug: Bevacizumab | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma |
Study Start Date : | February 2004 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | July 2009 |

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Drug: Erlotinib
- Tarceva
- OSI-774
- To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma [ Time Frame: 3 years ]
- To determine the time to tumor progression
- to determine the duration of response
- to determine the median and overall survival of patients
- to determine the safety of the drugs administered [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137826
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Pasi A Janne, MD, PhD | Dana-Farber Cancer Institute |
Publications:
Responsible Party: | Pasi A. Janne, MD, PhD, Associate Professor, Medicine, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00137826 History of Changes |
Other Study ID Numbers: |
03-369 |
First Posted: | August 30, 2005 Key Record Dates |
Last Update Posted: | December 26, 2011 |
Last Verified: | December 2011 |
Keywords provided by Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute:
Mesothelioma Avastin Bevacizumab |
Tarceva OSI-774 Erlotinib |
Additional relevant MeSH terms:
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Bevacizumab Erlotinib Hydrochloride Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |