February 20 2008 - US Oncology Begins Phase II
US Oncology Research Begins Phase II Study of Docetaxel plus Oxaliplatin with or without Cetuximab in Advanced Gastric Cancer and/or Gastroesophageal Junction Adenocarcinoma
Dallas, January 8, 2008-US Oncology Research, an established community-based research operation specializing in Phase I - Phase IV cancer clinical trials, in conjunction with Sanofi-aventis and ImClone Systems, today announced it has initiated a Phase II study of docetaxel plus oxaliplatin (DOCOX) with or without cetuximab in patients with metastatic gastric and/or histologically confirmed stage IV gastroesophageal junction (GEJ) adenocarcinoma. The trial's first patient was enrolled November 27 at Texas Oncology-Tyler Cancer Center, a US Oncology network practice.
The Phase II trial for this indication was based on an earlier large multi-institutional Phase II trial of DOCOX in patients with metastatic gastric or adenocarcinoma of the GE junction that showed DOCOX produced manageable toxicity in patients with advanced gastric cancer and adenocarcinoma of the GE junction, with response rates and overall survival comparable to standard front-line regimens. The data for that study were presented at the American Society of Clinical Oncologists (ASCO) 2006 Annual Meeting.
"In this new trial, we propose using the combination of docetaxel and oxaliplatin with the addition of cetuximab in a population identical to the initial trial," said Donald Richards, M.D., Ph.D., lead investigator, of Texas Oncology-Tyler Cancer Center and a member of the US Oncology network. "This trial allows the exploration of an anti-EGFR agent's activity in this disease and allows for comparison to recently published data."
Gastric cancer continues to be a significant health issue, second only to lung cancer as a leading cause of cancer deaths worldwide. Despite the high worldwide incidence of this malignancy and the rapid rise in the occurrence in proximal disease, progress in the treatment of gastric cancer has been limited. While multiple chemotherapeutic agents and combination regimens have demonstrated reproducible activity in advanced gastric and GE junction malignancies, no single regimen has become universally accepted as the international standard of care. Systematic chemotherapy has been compared to best supportive care and has resulted in improved overall survival; recent large phase III trials have demonstrated that effective therapy results in significant improvements in quality of life. Despite these advances, the median survival for patients with stage IV gastric cancers and adenocarcinoma of the GE junction remains only 9-10 months.
The Phase II trial of DOCOX with or without cetuximab in patients with metastatic gastric and/or GE junction adenocarcinoma will enroll 150 people with stage IV gastric gastroesophageal adenocarcinoma in a multicenter, open-label, randomized, noncomparative trial to determine the progression-free survival produced by the combination of docetaxel plus oxaliplatin plus cetuximab. Accrual rates of 10 patients per month is anticipated. Patients will be followed for two years, and the anticipated length of time for study completion is 3.4 years. The research previously presented at ASCO showed the results of the efficacy and tolerability of combined docetaxel plus oxaliplatin (DOCOX) in gastric cancer patients. DOCOX produced manageable toxicity in patients with advanced gastric cancer and adenocarcinoma of the GE junction. The confirmed response rate was 36 percent, clinical benefit rate of 40 percent, and median survival of 8.5 months were encouraging and comparable to standard front-line regimens. Cetuximab is a recombinant chimeric monoclonal antibody directed against the human epidermal growth factor receptor (EGFR); the agent is of interest in adenocarcinoma of the GE junction. Increased levels of EGF receptors have been associated with poor prognosis in gastric cancer. Because over-expression of EGFR has also been reported in this disease, adenocarcinoma of the GE junction or stomach appears to be a good candidate for therapy with anti-EGFR agents combined with combination chemotherapy.
About US Oncology Research
The US Oncology Research Network is an established community-based research operation specializing in all phases of cancer clinical trials. The research network currently has 500 physicians actively enrolling patients, 77 research sites, and is currently involved in more than 60 open research trials. The network has contributed to the development of 24 of 30 of the latest cancer-fighting drugs approved by the Food and Drug Administration for use. Since 1993, more than 32,000 patients have participated in clinical trials managed by US Oncology network practices. For more information, visit the "Research" section under "Our Services" on the company's Web site, www.usoncology.com.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).
About ImClone Systems
ImClone Systems (NASDAQ: IMCL) ImClone Systems Incorporated is a fully integrated biopharmaceutical company committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors.