NCT00137826

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mesothelioma

Interventions

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

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-03-01
• Completion: 2009-07-01
• First posted: 2005-08-30
• Last updated: 2011-12-26

Locations

3 sites across 1 country: United States