MesotheliomaPhase 2NCT00137826
Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
A Phase 2 study testing Erlotinib and Bevacizumab in people with Mesothelioma, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Erlotinib and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2004to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
The University of Chicago
Chicago, Illinois, 60637
About this study
Official title: Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
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.
Read the 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.
- Conditions
- Mesothelioma
- Being tested
- Erlotinib, Bevacizumab
- Keywords
- Mesothelioma, Avastin, Bevacizumab, Tarceva, OSI-774, Erlotinib
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva, OSI-774
Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.
BevacizumabDrug
Also called Avastin
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startFeb 2004
- Primary completionMar 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Chicago
- Responsible party
- Principal investigator, Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Pasi A Janne, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137826
- Sponsor's protocol ID
- 03-369
- Status last verified
- Dec 2011
- First submitted
- 29 Aug 2005
- Last updated
- 26 Dec 2011
- Results posted
- No
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. doi: 10.1056/NEJMoa050753.
PubMed 16014882Perez-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.
PubMed 15310767
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT00137826
- Acronym / sponsor ID
- 03-369
- Conditions
- Mesothelioma
- Keywords
- Mesothelioma, Avastin, Bevacizumab, Tarceva, OSI-774, Erlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Chicago
- Study start
- Feb 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErlotinibAlso: Tarceva, OSI-774Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects. | Drug | – |
| BevacizumabAlso: AvastinGiven 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. | Drug | – |
Primary outcome
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
Time frame: 3 years
4 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
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2011.
- Background: PubMed 16014882Shepherd 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.
- Background: PubMed 15310767Perez-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.
- Dana-Farber Cancer Institute Lowe Thoracic Oncology ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasi A Janne, MD, PhD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib and Bevacizumab in people with Mesothelioma, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00137826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2011; AzTrials last refreshed its copy on 8 Nov 2026.