October 18, 2004 - New Orleans - A small study is the first to show that Celebrex, an anti-inflammatory pain killer, slows the progression of recurrent prostate cancer. The study was presented earlier this month at the 2004 annual Clinical Congress of the American College of Surgeons.
The trial did not measure any effect on prostate cancer tumors. But in a small group of men experiencing rising prostate specific antigen levels following primary treatment (a condition known as "biochemical recurrence"), Celebrex slowed, stabilized or reduced the level of PSA.
In this study, 24 men took the Celebrex twice a day for a year. Twenty-two of the men showed some positive effect.
"This is the first report of a Cox-2 inhibitor having a therapeutic effect in prostate cancer at any stage of the disease," Raj Pruthi, MD, FACS, assistant professor of surgery, University of North Carolina, Chapel Hill, said.
Oct 18, Pfizer, maker of Celebrex, announced a new clinical trial to find out whether Celebrex has any cardiovascular side effects. For more information see related news linkbelow.
Although the rate of increase of PSA was moderate or high in 17 of the men in the study before treatment, it was slow, stable, or decreased in 22 men who received 400 mg or 800 mg of celecoxib twice a day for three months. At the end of a year of therapy, only one man had a high rate of increase of PSA, and three had a moderate rise in PSA. The remaining 20 men had delayed, stable, or decreased PSA levels.
Cox-2 inhibitors as antitumor medications are being studies by other investigators as treatment for a variety of cancers. According to Dr. Pruthi, thirteen National Cancer Institute (NCI)-sponsored studies began exploring Cox-2 inhibitors for colon, prostate, and breast cancer in 2003 and 34 NCI-studies started looking at these drugs for cancers of the head and neck, lung, and bladder in 2004.
Interest in Cox-2 inhibitors as a potential cancer treatment is increasing because of its ability to interfere with the body's repair mechanism, which is out of control in the presence of cancer.
Cox-2 inhibitors interfere with the action of cycloxygenase-2, an enzyme involved in prostaglandin synthesis, cell proliferation, and angiogenesis in a variety of disease processes.
"The Cox-2 enzyme is not normally expressed in the body. But if there is illness or injury, the body begins to produce Cox-2 to increase blood flow, create inflammation, and promote epithelial cell growth that will help it heal. The same processes occur in tumor development: excessive cell growth, angiogenesis [blood vessel generation], and excessive inflammation with cellular mediators and growth factors. Drugs that inhibit Cox-2 appear to work to prevent angiogenesis and to promote apoptosis [natural programmed cell death]," Pruthi said.
Pruthi and his colleagues are beginning to test the Cox-2 inhibitor in other groups of men with prostate cancer. He is planning a study of the drug as adjuvant therapy in men with advanced disease as well as those at high risk for recurrence immediately after surgery.
The potential role of Cox-2 inhibitors in men with prostate cancer is supported by large-scale epidemiological investigations as well as animal studies. Population studies have shown that men who take anti-inflammatory drugs have less than half the risk of developing prostate cancer. In animal experiments, prostate tumors have shrunk in size by a factor of ten after being exposed to a Cox-2 inhibitor, Pruthi said.
"The potential for anti-inflammatory medicines to have an antitumor effect has been observed for some time. We're just at the beginning of understanding the possibilities," he concluded.
J. Eric Derksen, MD and Eric Wallen, MD, FACS, joined Dr. Pruthi in the study of celecoxib in men with recurrent prostate cancer.
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NCI notice of continuing Phase II clinical trial:
Phase II Study of Celecoxib in Patients With Prostate Cancer in Biochemical Relapse After Prior Definitive Radiotherapy or Radical Prostatectomy. Note -- the phone number on this trial listing is wrong. The correct number for Dr. Pruthi's office is 919-966-2571 ext. 4
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Pfizer press release on safety of Celebrex, Oct 1 2004. "No Evidence of Cardiovascular Safety Signal for Pfizer's Celebrex in Long-Term Clinical Trials of More Than 6,000 Patients ÂData demonstrate that Celebrex does not increase the risk of heart attack or stroke in patients with arthritis and pain, even at higher-than-recommended doses .... Pfizer Inc said today that three large long-term Celebrex (celecoxib capsules) studies involving more than 6,000 patients have not shown any significant safety issues and are expected to continue to completion."
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Edited by J. Strax, Oct 18, 2004
