Fox Chase Cancer Center Leads New International Clinical Trial Evaluating Two Anti-Angiogenic Therapies for Prevention of Kidney Cancer Recurrence

PHILADELPHIA — In 2006, researchers announced significant improvements in the treatment of kidney cancer, a disease highly resistant to therapy. Most of the recent progress involves two new drugs approved by the U.S. Food and Drug Administration (FDA.). The drugs are sunitinib (Sutent) and sorafenib (Nexavar). Both are approved for the treatment of advanced renal cancer.

It is unknown if either sunitinib or sorafenib will benefit patients with other stages of kidney cancer until new studies are completed. In a new clinical trial, researchers will compare sunitinib and sorafenib to see if either or both can improve survival for patients at risk of having their disease recur after surgery. Currently, there is no standard treatment for these patients.

Led by researchers at Philadelphia's Fox Chase Cancer Center, the study is a randomized, double-blinded, phase III clinical trial being conducted at sites across the U.S. and Canada. It aims to accrue 1,332 patients over the next four years. Fox Chase medical oncologist Naomi Haas, M.D., is the principal investigator. The study is sponsored by the Eastern Cooperative Oncology Group (ECOG) and is supported by Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute.

"Sunitinib and sorafenib target pathways within cells that contribute to the cancer's spread," explained Haas. "Also, both drugs have been shown to prevent angiogenesis, a process allowing the growth of new blood vessels needed to feed cancerous tumors. Without a blood supply, the tumor can't grow."

Because there is no standard treatment for patients at risk of recurrence, the clinical trial will contain a placebo, or inactive pill, for comparison purposes. That means some patients will be assigned at random ("randomized") to receive either sorafenib or sunitinib and some will receive pills that look like the drugs, but are inactive (placebo).

This study design allows researchers to compare patients taking active drugs with those taking the placebo to see if either drug is effective. Placebo pills are not offered to patients in any clinical trial when a therapy known to benefit the patient exists.

To find out more information about this study call 888 FOX CHASE. Ask for information about the ASSURE study.

According to the American Cancer Society, kidney cancer is expected to strike nearly 39,000 Americans this year, and kill nearly 13,000. The disease is difficult to detect because it frequently shows no symptoms until it is very advanced. It is also highly resistant to treatment.

For additional information visit the Center's kidney cancer treatment website.

Fox Chase Cancer Center was founded in 1904 in Philadelphia, Pa. as the nation's first cancer hospital. In 1974, Fox Chase became one of the first institutions designated as a National Cancer Institute Comprehensive Cancer Center. Fox Chase conducts basic, clinical, population and translational research; programs of prevention, detection and treatment of cancer; and community outreach. For more information about Fox Chase activities, visit the Center's web site at www.fccc.edu.