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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 (Traveca, OSI-774) Drug: Bevacizumab (Avastin) Phase II
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:
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 yourself although unable to carry out work activities
- 4 or more weeks since last major surgery
- 4 or more weeks since last radiation therapy
- 3 or more weeks since last chemotherapy
- Life expectancy of 12 weeks or more
- Blood tests that show your 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 your
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 you
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
Study ID Numbers: 03-369
Last Updated: August 29, 2005
*** POSTED
NOVEMBER 9, 2005 ***
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