Sorafenib Clinical Trials Conducted in 11 States

Mesothelioma News

Mesothelioma Patients Being Recruited for Sorafenib Study

WASHINGTON, DC — August 5, 2005 — The National Cancer Institute is sponsoring a clinical trial to test the effectiveness of sorafenib in the treatment of mesothelioma, a severe cancer caused by asbestos exposure. Sorafenib’s manufacturers have already applied to have the drug approved for the treatment of advanced kidney cancer, based on promising clinical studies.

Also known as BAY 43–9006, sorafenib belongs to the family of drugs called raf kinase inhibitors. These drugs inhibit enzymes that may be responsible for tumor cell growth and division. Sorafenib may also block the growth of blood vessels necessary for mesothelioma tumor survival. The drug is said to stop tumor angiogenesis, the process of forming new blood vessels from pre–existing blood vessels.

Who is Eligible to Take Part in the Mesothelioma Study?

To participate in the study, mesothelioma patients must be over 18 years of age. They may have pleural mesothelioma, the most common form of the disease that affects the membranes lining the lungs and chest. Researchers will also accept patients with forms of mesothelioma that originate in the membranes surrounding other organs such as the pericardium (the heart) or the peritoneum (the stomach).

Eligible patients will not have had radiation therapy within the last four weeks or surgery within the last three weeks. They may not have had more than one mesothelioma treatment with ALIMTA^® (pemetrexed), an approved chemotherapy agent for pleural mesothelioma. For more detailed requirements, see Phase II Study of Sorafenib, NCI Information for Health Professionals.

Are Sorafenib Effects Monitored?

Study patients will receive sorafenib by mouth twice a day for 28 days. As long as the patient benefits, he or she will continue the mesothelioma treatment in 28–day cycles. After treatment is completed, doctors will evaluate patients at least every two months for the first year, every four months for the second year, and then every six months.

Clinical trials such as the sorafenib study are divided into phases. The current sorafenib study is a phase II trial.

A phase I clinical trial involves a small number of people. It explores how a drug works, whether it is effective, and whether it has side effects. A phase II clinical trial involves more participants and further evaluates the drug’s effectiveness, safety, and side effects. A phase III study goes into more detail, and may compare the new treatment with a more traditional treatment.

How Do I Participate in This Study?

The sorafenib clinical trial is being conducted at clinics, hospitals and cancer centers in 11 states. For the complete list, see Phase II Study of Sorafenib, NCI Patient Information. If you are interested in participating, talk to your doctor about a referral or call the appropriate trial contact person mentioned in the facility list.

See Learning About Clinical Trials for more information about how clinical trials work. You may also want to read Choosing a Mesothelioma Treatment That is Right for You and our section on Chemotherapy. Although we try to provide general information, any treatment decision should be based on extensive discussions with your treating physicians.

If you would like to know about your legal rights concerning mesothelioma, please feel free to contact us at Brayton Purcell. We have been handling cases involving mesothelioma and asbestos exposure for over 20 years and can provide support, information, and excellent advocacy.