The study in colorectal cancer is being conducted to determine whether survival is prolonged in patients with metastatic colorectal cancer treated with Erbitux in combination with the chemotherapeutic agent irinotecan compared with irinotecan alone, after best available first-line chemotherapy has failed.
The 1,300 patients enrolled in this study, which began enrollment in June 2003, were recruited from 250 centers worldwide. The study is being conducted jointly by Bristol-Myers Squibb, ImClone Systems and Merck KGaA.
The head and neck cancer study has enrolled 442 patients with recurrent and/or metastatic head and neck cancer who were randomized to receive cisplatin/carboplatin plus 5-FU with or without Erbitux. The study started in December 2004 and is being conducted in 89 centers across Europe.
In lung cancer 1,124 patients with stage IIIb/IV lung cancer who had not received previous chemotherapy have been recruited. Patients have been recruited from 173 centers worldwide and were randomized to receive either Erbitux in combination with standard first-line chemotherapy or standard chemotherapy alone. This study, known as FLEX, is the first among several first- and second-line, registrational studies of Erbitux in lung cancer to complete enrollment.
“The full enrollment of these studies in three major tumor types is indicative of the breadth of the global Erbitux clinical development program,” said Dr Eric Rowinsky, chief medical officer of ImClone Systems. “The Erbitux clinical development plan, of which these studies are the foundation, seeks to conclusively answer key questions about the drug’s ability to prolong survival in a variety of settings and tumor types.”