Irinotecan and thalidomide in metastatic colorectal cancer.

Fifteen patients with metastatic colorectal cancer were treated with irinotecan (CPT-11, Camptosar) at 300 to 350 mg/m2 every 21 days and thalidomide (Thalomid) at 400 mg/d. Of the 15 patients, 11 were in a pilot study and 4 were in an ongoing phase II protocol. There were 12 men and 3 women, with a median age of 56 years (range: 29 to 79 years). Patients were treated with a median of three cycles (range: one to eight cycles). The four patients enrolled in the formal protocol were not evaluable for response at the time of this report. Of the 11 patients in the pilot study, 10 were evaluable for response; there were two complete responses, two partial responses, and six progressions. Investigators noted a remarkable absence of grade 3/4 gastrointestinal toxicities, and concluded that further testing of the complete response and toxicity profile of the irinotecan/thalidomide regimen was warranted.