Half of Patients Do Not Respond to First-Line Chemotherapy; Investigational Therapy May Prevent Surgical Removal of Bladder
Recruiting Participants for Ongoing Study of Treatment With Breast-Cancer-Drug Abraxane® for Bladder Cancer
Feb 26, 2008
As many as half of patients with superficial bladder cancer do not respond to the standard first-line chemotherapy placed into the bladder, according to current multi-center outcomes data. When this happens, typically, their only option is surgical removal of the bladder. Now, researchers at the Herbert Irving Comprehensive Cancer Center of NewYork-Presbyterian Hospital and Columbia University Medical Center are investigating an FDA-approved metastatic breast-cancer drug called Abraxane® that may prove a safe and effective alternative to surgery for these patients.
Bladder cancer is the fourth leading cause of cancer in men and the ninth leading cause of cancer in women in the United States. In a given year, more than 60,000 new cases are diagnosed, and 13,000 will die from the disease.
"When the standard treatment does not work, currently the only option is surgical removal of the bladder—something that, for all patients, is unappealing, and for some sicker patients is not even possible. With this study, we hope to find an effective second line medical option for these patients," says Dr. James McKiernan, director of urologic oncology at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center, and vice chairman of the Department of Urology and assistant professor of urology at Columbia University College of Physicians and Surgeons.
The Phase I/II study will follow 18 patients for six weeks to assess dosage safety, followed by a second group of 19 patients who will be followed for six weeks to measure the effectiveness of the therapy.
The study is open to patients with recurrent bladder cancer that has not responded to standard therapy—BCG (bacillus Calmette-Guerin) treatment.
In 2006, Dr. McKiernan, together with departmental chair Dr. Mitchell C Benson, led a phase I study of the drug Taxotere, also used to treat breast cancer, on a similar patient population, finding the drug to be safe with 12 of 18 patients responding (results were published in the July 1, 2006, Journal of Clinical Oncology). Since then, a favorable percentage of patients have survived with intact bladders.
Abraxane, he believes, will show similar or better results. "Abraxane has an analogous structure to Taxotere, but has the advantage of being more soluble due to its solvent-free formulation allowing for administration at higher concentrations," says Dr. McKiernan. "In one study of Abraxane for metastatic breast cancer, the drug successfully shrank tumors and had few side effects."
The study is funded by Abraxis Bioscience of Los Angeles, California.
Those interested in enrolling in this study should contact Dr. McKiernan, Dr. Benson or study coordinator Melissa Laudano at 212-305-6665.
Herbert Irving Comprehensive Cancer Center
The Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center and NewYork-Presbyterian Hospital encompasses pre-clinical and clinical research, treatment, prevention and education efforts in cancer. The Cancer Center was initially funded by the NCI in 1972 and became an National Cancer Institute (NCI)-designated comprehensive cancer center in 1979. The designation recognizes the Center's collaborative environment and expertise in harnessing translational research to bridge scientific discovery to clinical delivery, with the ultimate goal of successfully introducing novel diagnostic, therapeutic and preventive approaches to cancer. For more information, visit www.hicc.columbia.edu.
NewYork-Presbyterian Hospital—based in New York City—is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. It provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital is ranked with among the lowest mortality rates for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, public health professionals, dentists, nurses, and scientists at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. For more information, visit www.cumc.columbia.edu.