Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
This study is currently recruiting patients.
Verified by Dana-Farber Cancer Institute January 2007
Sponsors and Collaborators: |
Dana-Farber Cancer Institute
Massachusetts General Hospital
University of Chicago
|
Information provided by: |
Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: |
NCT00137826 |
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Purpose
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.
Condition
|
Intervention |
Phase |
Mesothelioma |
Drug: Erlotinib (Tarceva, OSI-774)
Drug: Bevacizumab (Avastin) |
Phase II |
MedlinePlus related topics: Mesothelioma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcomes: To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
Secondary Outcomes: 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
Expected Total Enrollment:
37
Study start: February 2004
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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00137826
Pasi Janne, MD, PhD
617-632-6049
Joan Lucca, RN
617-632-5403
Illinois
The University of Chicago, Chicago,
Illinois,
60637,
United States; Recruiting
Hedy Kindler, MD
hkindler@medicine.bsd.uchicago.edu
Tamara Guterz
tguterz@medicine.bsd.uchicago.edu
Oyewale Abidoye, MD, Sub-Investigator
Kathryn Bylow, MD, Sub-Investigator
Robert Doebele, MD, Sub-Investigator
Gregory Friberg, MD, Sub-Investigator
Melinda Gordon, MD, Sub-Investigator
Ou (James) Jin, MD, Sub-Investigator
Justin Kline, MD, Sub-Investigator
Michael Maitland, MD, Sub-Investigator
Blasé Polite, MD, Sub-Investigator
Thomas Roberts, MD, Sub-Investigator
Ravi Salgia, MD, Sub-Investigator
Ursina Teitelbaum, MD, Sub-Investigator
Peter Tothy, MD, Sub-Investigator
Hedy Kindler, MD, Principal Investigator
Massachusetts
Dana-Farber Cancer Institute, Boston,
Massachusetts,
02115,
United States; Recruiting
Pasi A. Janne, MD, PhD
617-632-6049
pjanne@partners.org
Joan Lucca, RN
617-632-5403
Pasi A Janne, MD, PhD, Principal Investigator
Pamela Calarese, NP, Sub-Investigator
Bruce E Johnson, MD, Sub-Investigator
David Kwiatkowski, MD, PhD, Sub-Investigator
Michael Rabin, MD, Sub-Investigator
Geoffrey Shapiro, MD, PhD, Sub-Investigator
Arthur Skarin, MD, Sub-Investigator
Massachusetts General Hospital, Boston,
Massachusetts,
02114,
United States; Recruiting
Panos Fidias, MD
617-726-9298
Patricia Ostler, RN
617-724-7829
Panos Fidias, MD, Principal Investigator
Geoffrey Liu, MD, Sub-Investigator
Thomas Lynch, MD, Sub-Investigator
Jennifer Temel, MD, Sub-Investigator
Study chairs or principal investigators
Pasi A Janne, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
More Information
Dana-Farber Cancer Institute Lowe Thoracic Oncology Program
Publications
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.
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.
Study ID Numbers:
03-369
Last Updated:
January 18, 2007
Record first received:
August 29, 2005
ClinicalTrials.gov Identifier:
NCT00137826
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2007-01-30
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