New York, NY, June 17, 1996 -- For the first time in nearly 40 years there is a promising new drug in the United States approved by the FDA for the treatment of colorectal cancer. The drug, called CPT-11 or Camptosar, was cleared on June 14 by the FDA, under its accelerated approval regulations, for use as a second line treatment in patients whose disease has recurred or progressed after standard therapy. Dr. Leonard B. Saltz, of the Gastrointestinal Oncology Service at Memorial Sloan-Kettering Cancer Center is the lead investigator of a large-scale, international, multi-center study that will evaluate the use of the new drug as a first line therapy for colorectal cancer patients with metastatic disease. The study will be supported by Pharmacia & Upjohn, Inc., the company which has overseen the development of the drug in the United States.
"We know from preliminary studies at our institution and others that CPT-11 is safe and has activity in some patients when used in a second line setting -- after primary treatment has failed," said Dr. Saltz who is the lead investigator of the study. "But we also need to know more about the usefulness of CPT-11 when used for first line treatment, either alone, or in combination with standard chemotherapy," he added.
Standard chemotherapy for metastatic colon or rectal cancer usually involves the use of the drugs 5-fluorouracil (5FU) and leucovorin (LV). "Unfortunately many patients don't respond to these drugs, and most patients ultimately progress through their first line therapy. Until now, we have had no effective second line therapy to offer these patients, so we are very excited to have a more effective treatment option," said Dr. Saltz.
Researchers are planning to enroll approximately 660 patients over the next year who have newly diagnosed metastatic disease and have not been treated with chemotherapy or those who may have received adjuvant chemotherapy but have been disease-free for at least one year. About 50 centers throughout the U.S., Canada and Australia are participating in the Phase III trial.
Earlier recently published studies conducted at Memorial Sloan-Kettering showed a 32 percent response rate in 41 patients with colorectal cancer who had received no prior therapy. Dr. Saltz has recently reported the ability to give substantial doses of CPT-11 and standard chemotherapies together. "We are very encouraged by the anti-tumor activity of CPT-11 which has been found in patients who have received prior therapy as well as those who did not," said Dr. Saltz.
Colorectal cancer is the second leading cancer killer in the U.S. Each year 133,550 men and women in this country are diagnosed with the disease and in many of these cases, the disease has metastasized -- spread to other parts of the body. For patients interested in enrolling in the new study or for more information, call Memorial Sloan-Kettering at 1-800-525-2225 or Pharmacia & Upjohn, Inc., at 1-800-472-7811.
Memorial Sloan-Kettering Cancer Center is the world's oldest and largest private institution devoted to prevention, patient care, research, and education in cancer. Throughout its long, distinguished history, the Center has played a leadership role in defining the standard of care for patients with cancer. In 1995, Memorial Sloan-Kettering was named the nation's best cancer center for the third consecutive year by U.S. News & World Report.