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. Abo
Contact: Stacey Harris
Memorial Sloan-Kettering Cancer Center