Preliminary results from CINJ's Celebrex and Lipitor Phase II combination trial on prostrate cancer

Research from The Cancer Institute of New Jersey (CINJ) on the FDA-approved drugs Celebrex® and Lipitor® -- used respectively for arthritis pain and lowering cholesterol -- shows that these drugs are well tolerated in the treatment of recurrent prostate cancer. Preliminary results from an ongoing Phase II clinical trial will be presented during the 2012 Genitourinary Cancers Symposium, which is co-sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), and begins Thursday in San Francisco. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.

Previous 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. CINJ studies on laboratory models combining both of these drugs further showed both cell death and the prevention of cell growth in prostate cancer more effectively than either drug by itself. The goal of this current study was to determine whether a combination of these two drugs could stabilize or decrease previously rising prostate specific antigen (PSA) levels - which can be a biological indicator of the presence of prostate cancer.

The current research examined 16 adult patients who were diagnosed with localized prostate cancer (limited to the prostate), had a prostatectomy or radiation therapy, and subsequently had rising PSA levels consistent with disease relapse following treatment to the localized area. Participants were given two Celebrex® pills and one Lipitor® pill daily for six months. They were then followed every three months for a period of two years for PSA measurement and survival. Out of the 16 patients evaluated in this ongoing study, one withdrew from the trial and treatment was halted for two other patients due to progression of disease.

Researchers found that the combination of Celebrex® and Lipitor® "appears to be safe with minimal toxicity in the selected population." While research is ongoing, preliminary findings show a decrease in plasma levels of Lipitor®. The study also shows decreases in PSA levels, but in some patients these decreases were not sustained beyond two-to-three months. As a result, the dose of Lipitor® was doubled for future patients enrolled in the trial. Investigators note that outside of dizziness, no serious adverse events were reported, and overall the drug combination has been well tolerated.

Investigator Mark Stein, MD, a medical oncologist at the Gallo Prostate Cancer Center at CINJ and a member of CINJ's Phase I/Developmental Therapeutics Program, is presenting the poster. "While additional research is needed, this study is helping us better understand the mechanisms behind tumor activation and growth in prostate cancer. As a result we may be able to better identify effective therapies for recurrent prostate cancer," said Dr. Stein, who is also an assistant professor of medicine at UMDNJ-Robert Wood Johnson Medical School. "And by concentrating on drugs that already are FDA approved, we have the opportunity to bring new therapies to patients faster than if we were testing a brand new agent."

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