Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
1 other identifier
interventional
37
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2004
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedDecember 26, 2011
December 1, 2011
3.1 years
August 29, 2005
December 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
3 years
Secondary Outcomes (4)
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
3 years
Interventions
Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.
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.
Eligibility Criteria
You may qualify if:
- Mesothelioma that has been previously treated with at least one chemotherapy regimen
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Massachusetts General Hospitalcollaborator
- University of Chicagocollaborator
Study Sites (3)
The University of Chicago
Chicago, Illinois, 60637, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (2)
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.
PMID: 16014882BACKGROUNDPerez-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.
PMID: 15310767BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pasi A Janne, MD, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Medicine
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 30, 2005
Study Start
February 1, 2004
Primary Completion
March 1, 2007
Study Completion
July 1, 2009
Last Updated
December 26, 2011
Record last verified: 2011-12