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CONTACT: TOM MOORE
8798 John Pappajohn Pavilion
Iowa City IA 52242
(319) 356-3945
e-mail: thomas-moore@uiowa.edu

Release: Nov. 2, 2000

UI Health Care begins NSABP study for men and women with stage II or III colorectal cancer

IOWA CITY, Iowa -- University of Iowa Health Care is participating in Protocol C-07, a newly launched colorectal cancer trial. The study will test the benefits of oxaliplatin in combination with the current standard of treatment, 5-fluorouracil + leucovorin (5-FU+LV), in men and women with resected Stage II or Stage III colorectal cancer.

In the adjuvant setting, treatment with 5-FU+LV has been shown to significantly prolong disease-free survival and survival in colorectal cancer patients. Previous studies have suggested that oxaliplatin, a new platinum-based cancer treatment, in combination with 5-FU+LV produces a synergistic response increasing the effectiveness of the treatment, making tumor recurrence less likely. Findings from C-07 may result in this drug combination being deemed a first-line treatment for improving disease-free survival and overall survival of colorectal cancer patients in the adjuvant setting.

"University of Iowa Health Care is a leader in colorectal care in Iowa, and we are excited to join more than 100 medical centers from across the United States and Canada to participate in Protocol C-07," says Peter Jochimsen, M.D., a surgical oncologist in the Holden Cancer Center at the UI. "We are hopeful that, by adding oxaliplatin to the standard treatment of 5-FU+LV, we can increase the cure rate for colon cancer. This study is a very important first step that could change how physicians treat this disease, thereby setting the stage for total domination of this cancer later in the 21st century; and we look forward to its results."

In this study, 2,400 eligible patients will be randomly assigned to 5-FU+LV, or the 5-FU+LV and oxaliplatin, study group. Group 1 (n=1,200) will receive a total of three cycles (one cycle equals eight weeks; six weeks on drug and two weeks off) of 5-FU+LV. Group 2 (n=1,200) will receive the same 5-FU+LV regimen, plus oxaliplatin on weeks one, three, and five of each cycle. Both groups will receive a 21-day test period after each treatment cycle. Regardless of dose modifications or delays, therapy will not continue past 30 weeks.

Patients who have had a resection for a potentially curable stage II or III carcinoma of the colon will be considered for entry into this study. Other primary eligibility requirements include: one or more primary colon tumor(s); a life expectancy of 10 years (excluding cancer diagnosis); and a tumor at least 12 cm from the anal verge on endoscopy. Patients will not be eligible to participate if any of the following conditions apply: prior invasive colon or rectal malignancy; current or past malignant colon tumors other than carcinoma; pregnancy or currently breast-feeding (oxaliplatin may cause fetal harm); and noncurative surgical resection or prior chemotherapy or radiotherapy for this malignancy.

"We are pleased to partner with the National Cancer Institute (NCI) and National Surgical Adjuvant Breast and Bowel Project (NSABP) to have the opportunity to explore the role of oxaliplatin in the adjuvant therapy of these patients," says Dan Welch, executive vice president, Sanofi-Synthelabo Inc. Sanofi Lilly Oncology, L.L.C., is a limited liability company established between Sanofi-Synthelabo Inc., the U.S. unit of the global health care company Sanofi-Synthelabo, and Eli Lilly Company, Indianapolis, Ind., also one of the world's premier pharmaceutical companies.

UI Health Care is part of the NSABP, the network of research professionals that will conduct Protocol C-07, which is sponsored by the NCI. NSABP Director of Medical Affairs and C-07 Protocol Officer Roy Smith, M.D., noted that "despite adjuvant chemotherapy, about one-third of patients with colorectal cancer will develop a recurrence within five years of surgery. Thus, there continues to be a need to evaluate new treatment strategies and more effective drugs or combinations of drugs to further improve outcome in these individuals in the hopes that one day there will be a cure for colon cancer."

Colorectal cancer is expected to strike over 130,000 men and women and almost 57,000 individuals will die from the disease in this year alone, according to American Cancer Society estimates. Treatment for colorectal cancer is more successful if detected early. Beginning at age 50, experts recommend that men and women be screened for colorectal cancer and should talk with their physician about appropriate screening methods. People who are considered high risk should undergo entire colon screening more frequently beginning at a younger age.

For more information on Protocol C-07: A Clinical Trial Comparing 5-Fluorouracil (5-FU) Plus Leucovorin (LV) and Oxaliplatin with 5-FU Plus LV for the Treatment of Patients with Stages II and III Carcinoma of the Colon, please call UI Health Access at 800-777-8442 or visit NSABP's Web site at http://www.nsabp.pitt.edu or NCI's clinical trials Web site at http://www.cancertrials.nci.nih.gov.

University of Iowa Health Care describes the partnership between the UI College of Medicine and the UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide.