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

This study is ongoing, but not recruiting participants.
Information provided by Dana-Farber Cancer Institute

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Descriptive Information Fields
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 II
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary Outcome Measure  To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measure  To determine the time to tumor progression [ Time Frame: TBD ] [ Designated as safety issue: No ]
to determine the duration of response [ Time Frame: TBD ] [ Designated as safety issue: No ]
to determine the median and overall survival of patients [ Time Frame: TBD ] [ Designated as safety issue: No ]
to determine the safety of the drugs administered [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Condition  Mesothelioma
Intervention  Drug: Erlotinib
Drug: Bevacizumab
MEDLINE PMIDs 16014882,   15310767
Links Dana-Farber Cancer Institute Lowe Thoracic Oncology Program This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  37
Start Date  February 2004
Completion Date March 2009
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 Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00137826
Organization ID 03-369
Secondary IDs ††
Study Sponsor  Dana-Farber Cancer Institute
Collaborators †† Massachusetts General Hospital
University of Chicago
Investigators 
Principal Investigator:     Pasi A Janne, MD, PhD     Dana-Farber Cancer Institute    
Information Provided By Dana-Farber Cancer Institute
Verification Date December 2007
First Received Date  August 29, 2005
Last Updated Date December 20, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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