The Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma clinical trial held in both Boston, Massachusetts and Chicago, Illinois determined the physiological response to the combination of Bevacizumab and Erlotinib drugs in previously-treated malignant mesothelioma. The trial’s secondary goals included determination of the time to tumor progression, duration of response, median and overall survival of patients and the safety of the drugs administered.
The study, which was last updated on ClinicalTrials.gov on October 30, 2009, had an enrollment of 37 patients. The study began in February 2004 and ended in July 2009 with a primary completion date of March 2007.
Malignant mesothelioma is a rare type of cancer in the lining of the chest or abdomen. Those with exposure to airborne asbestos particles are more likely to develop mesothelioma, which is typically treated in mesothelioma clinics with surgery, radiation therapy, chemotherapy, or a combination of the three.
Both men and women, 18 years and older, diagnosed with malignant mesothelioma disease and previously treated with at least one chemotherapy regimen were eligible to participate in the trial, as long as a minimum of four weeks had passed since the subjects’ last major surgery or radiation therapy and at least three weeks had passed since their last chemotherapy treatment. All volunteers needed a life expectancy of at least 12 weeks and had to be able to walk and take care of themselves. All recruits were required to give informed consent and have adequate bone marrow, kidney and liver functions in order to participate. Healthy volunteers were not accepted in the trial.
Potential participants were not included in the study if they had prior exposure to Tarceva, trastuzumab, ZD1839 or C225. If patients had received anticoagulation medication other than Coumadin or had clinically significant heart disease or a history of central nervous system disease they were also excluded from the study. Pregnant or lactating female patients were not included in the trial.
Patients with a history of coughing up more than 1/4 teaspoon of blood or who had a serious or non-healing wound, ulcer or bone fracture were unable to participate in the study, and individuals who underwent a major surgery within 28 days of the screening for the study were also excluded. Daily treatments of aspirin or anti-inflammatory medications and difficulty swallowing were also factors for patient exclusion.
Patients accepted into the trial received Erlotinib orally, once daily, until either the disease progressed or they experience serious side effects. Patients were also intravenously administered Bevacizumab over a 30-90 minute time period on day 1 of each 21-day cycle until either the disease progressed or the patient experienced serious side effects. CT scans, MRI(s) and other x-rays were performed every six weeks.
Additional information for the Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma clinical trial can be found at http://www.dana-farber.org/pat/adult/thoracic-cancer/ or via email: Dana-FarberContactUs@dfci.harvard.edu.
The toll free telephone number for more information is (866)408-3324.
Mesothelioma.com is a trusted Internet resource for information about mesothelioma treatment, and includes a section devoted to clinical trials for mesothelioma cancer patients. Mesothelioma.com is also on Facebook and provides news and other information via Twitter @Mesodotcom.
