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

December 23, 2011 updated by: Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

December 26, 2011

Last Update Submitted That Met QC Criteria

December 23, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-369

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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