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

August 29, 2005
December 23, 2011
February 2004
March 2007   (final data collection date for primary outcome measure)
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 ]
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma.
Complete list of historical versions of study NCT00137826 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mesothelioma
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
July 2009
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00137826
03-369
Not Provided
Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • University of Chicago
Principal Investigator: Pasi A Janne, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP