Cancer Institute of New Jersey offers COMET-2 clinical trial to examine cabozantinib drug

The Cancer Institute of New Jersey is one of 50 sites across the nation to offer a clinical trial known as COMET-2 that examines whether the drug cabozantinib is effective in reducing bone pain in patients with prostate cancer that is no longer responsive to hormone therapy and has spread (metastasized) to other parts of the body. Researchers will compare results in patients receiving cabozantinib to those in patients who are receiving a standard treatment of mitoxantrone and prednisone for pain.

Studies have shown that bone metastasis and pain can be debilitating to patients with this type of cancer, known as castration-resistant prostate cancer, and can contribute to poor health and even death. While some therapies are able to treat bone metastasis and associated pain in this patient population, they are not effective for everyone. That is why investigators at the Cancer Institute of New Jersey are taking part in this national trial, sponsored by Exelixis, to examine the effects of cabozantinib.

Two types of 'receptors' on the surface of cells are able to receive messages that can promote tumor development and growth, eventually leading to metastasis. Cabozantinib is a drug known to block these receptors. Ongoing studies examining cabozantinib suggest that it can shrink prostate cancer in the bone in some men and also is associated with pain relief and a reduction in the use of narcotic drugs for pain control.

Patients accepted into the study will randomly be assigned to receive either cabozantinib or standard mitoxantrone/prednisone treatment. Throughout the study, participants will be asked to provide information about their level of pain and quality of life related to their health.

Mark Stein, MD, medical oncologist at the Cancer Institute of New Jersey and assistant professor of medicine at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, is the lead Cancer Institute of New Jersey researcher on the new study. "There remains a lack of effective therapies for this patient population with regard to pain. By further exploring drugs that can potentially slow or halt cancer metastasis while also addressing pain, we have an opportunity to develop treatments that can also afford them a better quality of life while they are undergoing therapy," he said.

Adults who are diagnosed with castration-resistant prostate cancer and have bone scan evidence of prostate cancer spreading to the bones are eligible to take part in the trial, although other criteria must also be met. Prior to being accepted into the study, participants would be required to undergo a number of tests including blood work and a physical exam.

Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer. At the Cancer Institute of New Jersey, researchers use these studies to answer questions about how a treatment affects the human body and to make sure it is safe and effective. There are several types of clinical trials that are currently underway at the Cancer Institute of New Jersey, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today, whether they are drugs or vaccines, ways to do surgery or give radiation therapy, or combinations of treatments, are the results of past clinical trials.