Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma - Full Text View

Sponsor:	Dana-Farber Cancer Institute
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

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 II

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

Drug Information available for: Erlotinib hydrochloride Erlotinib Bevacizumab

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:

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

Other Names:

Tarceva
OSI-774

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:

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.

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.

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 February 09, 2012