Irinotecan/thalidomide in metastatic colorectal cancer.

The prognosis for patients with metastatic colorectal cancer is poor. Use of irinotecan (CPT-11, Camptosar) results in modest response rates of approximately 20% in refractory patients diagnosed with this advanced stage of disease and offers a side-effect profile that improves on that of previous standard treatments. Thalidomide (Thalomid) has antiangiogenic properties, and angiogenesis has been shown to influence the outcome of colon cancer patients. A good response rate and acceptable tolerability regarding gastrointestinal effects were demonstrated in a pilot study of the irinotecan/thalidomide combination in patients with metastatic colorectal cancer. This combination is being assessed at the University of Arkansas for Medical Sciences as second-line therapy in a phase II trial. Patients with metastatic colorectal cancer are receiving 350 mg/m2 of irinotecan every 3 weeks plus 400 mg/m2/d of thalidomide. Preliminary response and safety data are presented for 18 enrolled patients.