Skip to main content
OpenTrials
Completed

NCT Number: NCT00137826

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Chicago, Chicago, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erlotinib

Drug

Taken orally once daily. Participants may continue on study treatment until disease progresses or they experience serious side effects.

Other names: Tarceva, OSI-774

Bevacizumab

Drug

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 names: Avastin

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. To determine the time to tumor progression

  2. to determine the duration of response

  3. to determine the median and overall survival of patients

  4. to determine the safety of the drugs administered

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Massachusetts General Hospital
  • University of Chicago

Registry information

Official study title

Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Aug 30, 2005
Registry last updated
Dec 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.