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

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137826
• Other study ID #: 03-369
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2005
• Last updated: December 23, 2011
• Start date: February 2004
• Est. completion date: July 2009

Study information

• Verified date: December 2011
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2009
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mesothelioma

Intervention

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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Massachusetts General Hospital, University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

Pérez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabárbara 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. — View Citation

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, Santabárbara 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma		3 years	No
Secondary	To determine the time to tumor progression		TBD	No
Secondary	to determine the duration of response		TBD	No
Secondary	to determine the median and overall survival of patients		TBD	No
Secondary	to determine the safety of the drugs administered		3 years	Yes