CHICAGO and ANN ARBOR, Mich., Sept. 27 /PRNewswire/ -- The Cancer and Leukemia Group B (CALGB) and Southwest Oncology Group (SWOG) today announced the initiation of a randomized, multicenter Phase III clinical trial designed to determine whether the addition of cetuximab to chemotherapy or to chemotherapy and bevacizumab prolongs survival compared to chemotherapy with bevacizumab in patients with untreated, advanced or metastatic colorectal cancer. The enrollment of 2,289 patients is already underway at the CALGB and SWOG networks of academic medical centers, community hospitals and private practices.
"Biologics are an important new part of the treatment paradigm in colorectal cancer and it is critical that we have a full understanding of when and where they are of greatest use," said Richard L. Schilsky, M.D., Group Chairman, CALGB. "This study addresses a question that many physicians are eager to have answered: Of our new treatment options in this disease, what combination of cetuximab, bevacizumab and chemotherapy will most benefit patients as the initial treatment of their advanced disease? We look forward to enrolling this trial rapidly and to answering this question as soon as possible."
"Cetuximab and bevacizumab have had a significant impact on the treatment of colorectal cancer, but as they are indicated for use in different stages of treatment, we have limited clinical information about their combined effect," said Alan Venook, M.D., Professor, Clinical Medicine, University of California, San Francisco, and co-Principal Investigator of the study. "There is optimism in the oncology community that the combination of cetuximab and bevacizumab will have a greater impact against this deadly disease, because they target two unique cellular functions and have each been shown to enhance the effectiveness of chemotherapy."
"This study is the result of a major collaborative effort between the research community, the National Cancer Institute and the pharmaceutical industry. It is indicative of the enthusiasm with which all parties seek to explore the best way to integrate targeted therapies to further improve the outcome of patients with advanced colorectal cancer." said Charles D. Blanke, M.D., Director of the Solid Tumors Program of the Oregon Health and Science University Cancer Institute, and co-Principal Investigator of the study. Dr. Blanke also is Chairman of SWOG's Gastrointestinal Committee.
Patients enrolled in the study will be randomized to one of three arms: 1) cetuximab with FOLFOX (a combination of oxaliplatin, leucovorin, and fluorouracil) or FOLFIRI (a combination of irinotecan, fluorouracil, leucovorin) chemotherapy; 2) cetuximab and bevacizumab with FOLFOX or FOLFIRI; and 3) bevacizumab with FOLFIRI or FOLFOX (the control arm). The study will also attempt to identify predictors of response to these therapies and will also look to confirm the reported 70% incidence of EGFR positivity in patients with advanced colorectal cancer.
CALGB member institutions can obtain the protocol from the CALGB web site, www.calgb.org. Institutions and physicians that are not members of CALGB may register patients through the NCI Cancer Trials Support Unit at www.ctsu.org.
The Cancer and Leukemia Group B (CALGB) is a national clinical research group sponsored by the National Cancer Institute, with its Central Office headquartered at the University of Chicago and its Statistical Center located at Duke University. The CALGB was founded in 1956 with a goal of bringing together clinical oncologists and laboratory investigators to develop better treatments for cancer. Since 1956, CALGB has grown into a national network of 29 university medical centers, over 225 community hospitals and more than 3000 oncology specialists who collaborate in clinical research studies aimed at reducing the morbidity and mortality from cancer, relating the biological characteristics of cancer to clinical outcomes and developing new strategies for the early detection and prevention of cancer.
Established in 1956, the Southwest Oncology Group is one of the largest cancer clinical trials cooperative groups in the United States. Supported by grants from the National Cancer Institute, the Group is a network of more than 5,000 of the nation's leading physicians at 644 institutions throughout the United States, Canada and Puerto Rico who focus on the prevention and treatment of cancer in adults. More than 7,000 patents are enrolled each year in the Group's 120 ongoing studies. Southwest Oncology Group has directly affected the lives of more than 170,000 patients enrolled in its clinical trials and million more who have benefited from the Group's successful research. The Federal Drug Administration has approved or expanded the approval of nine new cancer therapies as a direct result of Southwest Oncology Group research.
The Cancer and Leukemia Group B; Southwest Oncology Group