ABSTRACT
The development of novel chemotherapy agents and regimens for the treatment of patients with colorectal cancer remains an important focus of cooperative group research in the USA. New drugs are initially evaluated in single-or limited-institutional phase I trials that are less suited for cooperative group efforts. Agents with promising levels of activity and acceptable toxicity are subsequently evaluated in phase II and phase III cooperative group trials in the USA. Often, new agents and combinations are initially evaluated in patients with metastatic disease for evidence of activity prior to testing in the adjuvant setting. The cooperative groups provide an excellent opportunity for the design and conduct of large multicenter phase III trials to compare new therapies with accepted standard treatment. The evaluation of new molecular markers for potential prognostic significance is also an important goal of adjuvant trials conducted by the cooperative groups. In addition, the cooperative groups are beginning to explore phenotypic differences in tumors for the role these differences play in variability in response to particular chemotherapy agents. Finally, biological agents, whose activity may be greatest in patients with minimal residual disease, may best be evaluated by novel protocol designs being developed by the US cooperative groups.
