Patients eligible to participate in this study will be asked to consider a research consent form which includes the following information:

Purpose of This Research Study:

You have been asked to participate in this research study because you have malignant mesothelioma, a cancer of the lining around the lungs (pleura) or abdomen (peritoneum) that cannot be treated with surgery. The purpose of this study is to determine the effect on malignant mesothelioma of the investigational drug Bevacizumab as compared to placebo when added to gemcitabine and Cisplatin (a commonly used chemotherapy regimen for mesothelioma). Blood will also be collected for experimental tests to evaluate this treatment. Another purpose of the study is to collect and store blood samples for future research. Your treatment on this study is expected to last at least six weeks but may continue if your cancer is not growing and you are not experiencing any unmanageable side effects. After your treatment on this study is over, your medical condition will be followed indefinitely.

Background:

Patients with malignant mesothelioma have more angiogenesis factors (proteins in the blood that encourage the growth of new blood vessels) than patients with any other solid tumors. Bevacizumab is an experimental antitumor agent called an angiogenesis inhibitor. Angiogenesis inhibitors are believed to affect tumor cell growth by attacking the blood vessels that supply tumors with nutrition, rather than by attacking the cancer cells directly. It is thought that when new blood vessels are unable to form to feed a growing tumor, the tumor may shrink. Studies in animals indicate that Bevacizumab can decrease new blood vessel growth, cause tumors to decrease in size, and prevent tumors from spreading (metastasizing) in the body.ûûPrevious studies of gemcitabine and cisplatin have shown a higher than expected rate of temporary tumor shrinkage in malignant mesothelioma. This combination has become the standard treatment for malignant mesothelioma. This study will compare standard chemotherapy plus placebo (inactive substance) to standard chemotherapy plus the angiogenesis inhibitor Bevacizumab in terms of side effects on effect on malignant mesothelioma.

Contact:

Please call 1-877-482-HOPE(4673) or click here to contact City of Hope to receive information on new patient services and referral to one of our physicians.

*** POSTED AUGUST 3, 2004  ***