Name of the Trial
Phase III Randomized Study of Carboplatin and Paclitaxel with versus without Sorafenib in Patients with Unresectable Stage III or Stage IV Melanoma (ECOG-E2603). See the protocol summary at http://cancer.gov/clinicaltrials/ECOG-E2603.

Principal Investigators
Dr. Keith Flaherty and Dr. Lynn Mara Schuchter, Eastern Cooperative Oncology Group

Why Is This Trial Important?
Approximately 60,000 people in the United States will be diagnosed with melanoma in 2005. While early-stage melanoma is typically curable with surgery, melanoma that has spread (metastasized) is difficult to treat and often proves fatal.

In this clinical trial, researchers are testing chemotherapy with the drugs carboplatin and paclitaxel in combination with a new drug called sorafenib (BAY 43-9006). Sorafenib works by blocking the activity of proteins important for cell proliferation and for generating new blood vessels to tumors (angiogenesis). Many melanoma tumors carry a mutation in a gene called B-RAF, which in turn produces a protein called Raf kinase. This protein facilitates cellular processes that lead to tumor cell proliferation and survival. Sorafenib blocks the Raf kinase protein and interrupts these processes. It also inhibits a protein called vascular endothelial growth factor receptor (VEGFR), which helps tumors grow the blood vessels needed for nourishment. Researchers hope that sorafenib will weaken melanoma tumors and enhance the cell-killing effects of chemotherapy.

"No therapy has yet produced a clear survival benefit for patients with advanced melanoma," said Dr. Flaherty. "Because of the dual nature of sorafenib's activity and the results we have seen with this combination in an earlier study, we believe this therapy is the most promising so far for prolonging survival of these patients."

Who Can Join This Trial?
Researchers seek to enroll 800 patients aged 18 and over with stage III or stage IV melanoma that cannot be removed surgically. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/ECOG-E2603.

Where Is This Trial Taking Place?
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites at http://www.cancer.gov/clinicaltrials/ECOG-E2603.

Contact Information
See the list of study contacts at http://www.cancer.gov/clinicaltrials/ECOG-E2603 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.