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

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Chicago
Information provided by (Responsible Party):
Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00137826
First received: August 29, 2005
Last updated: December 23, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Drug: Bevacizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma
U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the time to tumor progression [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • to determine the duration of response [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • to determine the median and overall survival of patients [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • to determine the safety of the drugs administered [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: February 2004
Study Completion Date: July 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Erlotinib
    Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.
    Other Names:
    • Tarceva
    • OSI-774
    Drug: Bevacizumab
    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.
    Other Name: Avastin
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137826

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
University of Chicago
Investigators
Principal Investigator: Pasi A Janne, MD, PhD Dana-Farber Cancer Institute
  More Information

Additional Information:
Dana-Farber Cancer Institute Lowe Thoracic Oncology Program  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Pasi A. Janne, MD, PhD, Associate Professor, Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00137826     History of Changes
Other Study ID Numbers: 03-369
Study First Received: August 29, 2005
Last Updated: December 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Mesothelioma
Avastin
Bevacizumab
 Tarceva
OSI-774
Erlotinib

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Bevacizumab
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013