The FDA-approved drugs Celebrex® and Lipitor® used respectively for arthritis pain and lowering one’s cholesterol, are being tested by investigators at The Cancer Institute of New Jersey (CINJ) to see if they hold any promise in slowing or stopping the growth of prostate cancer when combined. CINJ is a center of excellence of UMDNJ-Robert Wood Johnson Medical School.

According to the American Cancer Society, prostate cancer affects one in six men; it is the most frequently diagnosed cancer in men, other than skin cancer, and the second leading cause of cancer death in men. Through a newly opened clinical trial, researchers aim to test the effectiveness of the combined drugs on those with early-stage prostate cancer.

Recent studies have shown that Celebrex® and Lipitor® individually have effects on blocking a protein complex known as nuclear factor kappa B (NFkB). NFkB plays a large role in the body’s immune system and in many cases can cause tumor cells to grow. By combining these drugs, scientists hope to prevent tumor cells from growing and make them more sensitive to cancer killing drugs.

CINJ is the sponsor of the trial, and the study will be offered through CINJ and its Flagship hospital Robert Wood Johnson University Hospital. Patients enrolled on the trial will be given a prescription to have the drugs filled at an outside pharmacy under their trade names, since a generic form for either medication is not available for sale in the United States. Celebrex® and Lipitor® are marketed in the U.S. by Pfizer.

Susan Goodin, PharmD, FCCP, BCOP, associate director of clinical trials and therapeutics at CINJ and professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the lead investigator of the trial. “Understanding the mechanism for tumor activation and growth may allow for targeting more specific tumor pathways for prostate cancer. And by focusing on drugs that already have FDA approval, we can potentially bring targeted therapies to patients faster than if we were testing a brand new compound or drug,” she noted.

Selected patients will undergo various testing before and during treatment, including blood work to detect prostate specific antigen (PSA) levels and CT or bone scans. For six months, participants will take both drugs by mouth daily. Following that period, patients will have their PSA levels assessed every three months for the next two years.

Patients at or above age 18 with a diagnosis of prostate cancer and rising PSA levels but has no evidence of prostate cancer on CT or bone scans are eligible to take part in the trial, although other criteria must be met. The study is part of the CINJ Oncology Group (CINJOG), which is comprised of physicians throughout New Jersey from the CINJ Network of hospitals. For additional information on how to participate, individuals should call 732-235-7251.

Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer. At CINJ, 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 CINJ, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today - whether it is drugs or vaccines; ways to do surgery or give radiation therapy; or combinations of treatments - are the results of past clinical trials.

As New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, CINJ provides patients with access to treatment options not available at other institutions within the state. CINJ currently enrolls more than 1,000 patients on clinical trials, including approximately 15 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in clinical trials nationwide is fewer than five percent of all adult cancer patients.

About The Cancer Institute of New Jersey
The Cancer Institute of New Jersey is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center, and is dedicated to improving the prevention, detection, treatment and care of patients with cancer. CINJ’s physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. The Cancer Institute of New Jersey is a center of excellence of UMDNJ-Robert Wood Johnson Medical School. To support CINJ, please call the Cancer Institute of New Jersey Foundation at 1-888-333-CINJ.

The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides a mechanism to rapidly disseminate important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, Jersey Shore University Medical Center. Affiliate Hospitals: Bayshore Community Hospital, CentraState Healthcare System, Cooper University Hospital*, JFK Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital at Hamilton (CINJ at Hamilton), Saint Peter’s University Hospital, Somerset Medical Center, Southern Ocean County Hospital, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton.

Source: Cancer Institute of New Jersey