Irinotecan is the only accepted second-line treatment for colorectal cancer
in the USA. Doses are, however, frequently limited by associated late-onse
t diarrhoea. Thalidomide has antiangiogenic and immunomodulatory properties
and is being investigated as an antineoplastic. We did a pilot study of co
mbination therapy with thalidomide and irinotecan for metastatic colorectal
cancer. In an interim analysis of nine patients, thalidomide had almost el
iminated the dose-limiting gastrointestinal toxic effects of irinotecan, es
pecially diarrhoea and nausea (each p<0.0001), and eight of nine patients w
ere able to complete the chemotherapy course.