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Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma

Primary Purpose

Mesothelioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Bevacizumab
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma focused on measuring Mesothelioma, Avastin, Bevacizumab, Tarceva, OSI-774, Erlotinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Chicago
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2005
Last Updated
December 23, 2011
Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00137826
Brief Title
Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
Official Title
Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, University of Chicago

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
Keywords
Mesothelioma, Avastin, Bevacizumab, Tarceva, OSI-774, Erlotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva, OSI-774
Intervention Description
Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To determine the time to tumor progression
Title
to determine the duration of response
Title
to determine the median and overall survival of patients
Title
to determine the safety of the drugs administered
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasi A Janne, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16014882
Citation
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.
Results Reference
background
PubMed Identifier
15310767
Citation
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.
Results Reference
background
Links:
URL
http://www.dana-farber.org/Adult-Care/Treatment-and-Support/Lung-Cancer,-Non-Small-Cell.aspx
Description
Dana-Farber Cancer Institute Lowe Thoracic Oncology Program

Learn more about this trial

Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma

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