CLINICAL TRIAL HIGHLIGHT: Regorafenib as maintenance therapy in colorectal cancer patients

by Wen Wee Ma, MBBS
Formerly of Roswell Park

Regorafenib (Stivarga®), a multi-kinase inhibitor of cancer cell growth and angiogenesis, was shown to improve survival of patients with metastatic colorectal cancer that had progressed after standard treatment. Subsequently, the U.S. FDA approved the drug in 2012 for the treatment of patients with refractory metastatic colorectal cancer. Current research now focuses on whether regorafenib treatment will benefit other colorectal cancer patients, and Roswell Park will be leading a multi-center clinical trial evaluating the use of regorafenib in patients with high-risk stage II and III rectal cancer after curative treatment (Roswell Park Clinical Trial # I246813; note: this trial requires IRB review and is not yet recruiting patients). Typically, these patients will undergo surveillance after adjuvant/post-operative therapy with routine imaging and clinic visits. In this clinical trial, patients will be offered regorafenib treatment in addition to routine imaging and clinic visits to determine whether such maintenance therapy will reduce the recurrence risk and prolong survival.

Also, Roswell Park is teaming up with other institutions in the ‘COAST’ trial to investigate the use of regorafenib maintenance therapy in colorectal cancer patients after curative resection of their liver metastases (Roswell Park Clinical Trial # PH241813; #NCT01939223).