Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
NCT ID: NCT00137826
Last Updated: 2011-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2004-02-29
2009-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Erlotinib
Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.
Bevacizumab
Given intravenously over 30-90 minutes, on day 1 of each 21-day cycle. Participants may continue on study treatment until disease progresses or they experience serious side effects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
University of Chicago
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Pasi A. Janne, MD, PhD
Associate Professor, Medicine
Principal Investigators
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Pasi A Janne, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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The University of Chicago
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
Perez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabarbara P, Bonomi P. Determinants of tumor response and survival with erlotinib in patients with non--small-cell lung cancer. J Clin Oncol. 2004 Aug 15;22(16):3238-47. doi: 10.1200/JCO.2004.11.057.
Related Links
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Dana-Farber Cancer Institute Lowe Thoracic Oncology Program
Other Identifiers
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03-369
Identifier Type: -
Identifier Source: org_study_id